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87 Study Matches

The Genetic, Protein, and Lipid Basis of Variation in Cholesterol Efflux

The rationale of this research is that deep phenotyping of individuals at the extremes of cholesterol efflux will identify key determinants of efflux that are potential novel therapeutic targets to prevent or reverse Atherosclerotic Cardiovascular Disease (ASCVD). The investigators propose to carry out the objective by studying participants at extreme low and high cholesterol efflux identified from the investigator's study in the population-based Dallas Heart Study by accomplishing the following aims: 1) determine the heritability of and genomic factors associated with cholesterol efflux by establishing a family pedigree of extreme low and high efflux and sequencing candidate genes involved in HDL metabolism; and 2) identify the protein and lipid signature of extreme low and high cholesterol efflux in a sex- and ethnicity-specific manner using mass spectroscopy and ELISA in FPLC-derived fractions. The investigators expect to identify genetic variants and sex- and ethnicity-specific combinations of proteins and lipids in participants with extreme low and high efflux that may lead to novel ways to modulate efflux. This proposal leverages a well-phenotyped population-based study to characterize the gene-protein-lipid signature of 1) extremes of cholesterol efflux in a sex- and ethnicity-specific manner. Successful completion of these aims will have immediate and direct impact on the use of cholesterol efflux as a clinically relevant biomarker of therapeutic benefit and are necessary for the clinical development of appropriate new targets for manipulation of the key atheroprotective function of cholesterol efflux to reduce ASCVD.
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Anand Rohatgi
77134
All
18 Years to 89 Years old
This study is also accepting healthy volunteers
NCT04061018
STU 042016-020
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Inclusion Criteria:

• Dallas Heart Study (DHS) Participants who are above or below the sex- and ethnicity-specific 10th and 90th% of cholesterol efflux.
• Family members of the DHS participants are also eligible
Exclusion Criteria:

• HIV
• Cancer
• Autoimmune diseases
• Pregnancy
Lipid Metabolism Disorders
HDL, Atherosclerotic Cardiovascular Disease, Cholesterol efflux
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Aneurysmal Subarachnoid Hemorrhage Trial RandOmizing Heparin (ASTROH)

A Blind-adjudication Multi-center Phase II Randomized Clinical Trial of Continuous Low-dose Intravenous Heparin Therapy in Coiled Low-grade Aneurysmal Subarachnoid Hemorrhage Patients with Significant Hemorrhage Burden.
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Babu Welch
67812
All
18 Years to 70 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02501434
STU 042016-042
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Inclusion Criteria:
1. Age ≥ 18 and ≤ 70 years 2. Historical modified Rankin Scale Score 0-1 3. WFNS SAH Scale grade ≤ 2, due to a spontaneous subarachnoid hemorrhage attributable to a ruptured cerebral aneurysm. Cranial nerve deficit (e.g. CN III paresis) is permissible even for WFNS grade 2. • Initial WFNS grade may be determined at admission or enrollment, preferably after the patient's mental status has been optimized by resuscitation and interval treatment of hydrocephalus (i.e., placement of intraventricular catheter) or reversal/wearing-off of sedating medications used commonly during patient transfers and transport or procedure related anesthesia. 4. Admission head CT showing modified Fisher grade 3 aSAH primarily in the supratentorial space. Snapshot images of up to four relevant axial cuts from the admission head CT will need to be uploaded via the imaging database to confirm the modified Fisher grade 3 eligibility of the potential subject prior to enrollment. Minimal intraventricular hemorrhage is acceptable. The Modified Fisher CT rating scale: Grade 1 (minimal or diffuse thing SAH without IVH); Grade 2 (minimal or thin SAH with IVH), Grade 3 (thick cisternal clot without IVH), Grade 4 (thick cisternal clot with IVH) [From: Claassen J et al. Effect of cisternal and ventricular blood on risk of delayed cerebral ischemia after subarachnoid hemorrhage: the Fisher scale revisited. Stroke 2001;32:2012-2020.] 5. Location and pattern of the SAH must have the majority of the SAH in the supratentorial space caused by either an intradural anterior circulation aneurysm OR a basilar apex posterior circulation aneurysm with primarily supratentorial hemorrhage extension. Angiographic location of the aneurysm will be confirmed by catheter digital subtraction angiography (DSA) usually obtained during the coil embolization procedure. Patients with PICA or other posterior circulation aneurysms as the cause of the SAH will be excluded. 6. Onset of symptoms of aSAH (ictus) occurred < 24 hours prior to presentation at the treating facility. 7. Initiation of aneurysm securement procedure occurred < 48 hours from the ictus AND less than 36 hours from admission to the treating facility. • In patients where the exact time of the ictus is uncertain, an estimated time of ictus may be assigned and that time will be used for the inclusion criteria above assuming the estimation is deemed to be reasonably reliable [i.e., actual time is highly likely to be within 6 hours of estimated time]. 8. All aneurysm(s) suspected to be responsible for the hemorrhage or potentially responsible for the hemorrhage must be secured in the following manner prior to enrollment: • Endovascular Coil Embolization with a post-embolization Raymond-Roy Score of 1 (Complete) or 2 (Residual Neck) 9. Ability to screen the patient and obtain a head CT 2-12 hours after the completion of the coiling procedure and then ability to initiate the study drug 12 ± 4 hours after the completion of aneurysm coiling procedure.. 10. After recovering from anesthesia following the aneurysm coiling procedure, the patient must remain a WFNS SAH grade ≤ 2 without evidence of a significant new focal neurological deficit including monoparesis / monoplegia, hemiparesis / hemiplegia, or receptive, expressive or global aphasia. New minor cranial nerve defect without any other new findings is permissible. If an NIHSS score was obtained prior to the aneurysm coiling procedure, a post-coiling (pre-enrollment) NIHSS score must not have increased by ≥ 4 points and GCS score must not be decreased by ≤ 2 points. The clinician at the local site should use their best clinical judgment as to whether a significant neurological decline has occurred due to the procedure. 11. Patient is willing and able to return for study follow-up visits. 12. Patient or their Legally Authorized Representative (LAR) has provided written informed consent.
Exclusion Criteria:
1. Angio-negative SAH. 2. A likely hemorrhage event within several days prior to admission related hemorrhage ictus due to the increased risk of early vasospasm. Prior sentinel headache with negative CT or prior sentinel headache where the patient did not seek medical attention does not exclude the patient. 3. Surgical clipping of the ruptured aneurysm or any non-ruptured aneurysm on the same admission prior to enrollment. 4. SAH not caused by aneurysm rupture or aneurysm is identified to be traumatic, mycotic, blister or fusiform type by catheter DSA. 5. Any intracranial stent placement or non-coil intra-aneurysmal device (i.e., stent- assisted coiling with Neuroform, Enterprise, LVIS, LVIS Jr, Barrel Stent, Pulse Rider, WEB, LUNA, Medina or a similar device) where the stent device is implanted to treat the ruptured aneurysm and / or antiplatelet therapy is needed. 6. Patient has remaining aneurysm(s) that are untreated and could reasonably be considered a possible alternate cause of the aSAH based on the observed bleeding pattern. Adequate treatment of these aneurysms by coiling embolization would result in the aneurysms no longer causing an exclusion. MRI may be used in some situations to determine that the associated aneurysms did not rupture based on lack of blood seen adjacent to the additional aneurysms. 7. Femoral arteriotomy stick above the inferior epigastric artery OR angiographic, CT, or clinical evidence of an arteriotomy related retroperitoneal hematoma or large flank hematoma. A stable groin hematoma is not an exclusion. 8. Patient received heparin in any form within the last 100 days prior to admission (not including coiling procedure). 9. Thrombocytopenia (platelet count less than 100,000
•assuming clumping has been ruled out as a cause), confirmed active disseminated intravascular coagulation (DIC) at the time of enrollment OR a documented history of coagulopathy or bleeding diathesis. 10. Diagnosis of sepsis (SIRS criteria plus the presence of known or suspected infection) or current documented active bacterial or viral infection prior to enrollment (Example: significant URI, community-acquired pneumonia). A minor non- complicated community-aquired urinary tract infection would not be an exclusion but should be treated promptly. 11. New parenchymal hemorrhage or new infarction larger the 15cc in volume, or significant increased mass effect as seen on the post coiling pre-enrollment head CT when compared to baseline admission head CT. New hyyperdensity on CT scan related to contrast staining is not an exclusion. 12. Patient has a documented history of heparin induced thrombocytopenia (HIT) 13. Patient developed SAH-induced cardiac stunning prior to enrollment, with an ejection fraction< 40%, or requiring IV medicaitons for blood pressure maintenance. 14. Pre-admission daily antiplatelet therapy or any oral or subcutaneous anticoagulation therapy prior to, or during the coil embolization procedure. A single 325 mg Aspirin (or lower dose) given duiring the coil embolization peri-procedural period is acceptable if this is the local standard of care, but should be documented. 15. Thrombolytic therapy within 24 hours prior to enrollment (rtPA, urokinase, etc.) 16. Plan for antiplatelet or oral anticoagulation therapy from the time of the coil embolization procedure until 14 full days after enrollment. Antiplatelet therapy may be resumed after the 14-day window. 17. Concurrent significant intracranial pathology identified prior to enrollment, including but not limited to, Moyamoya disease, high suspicion or documented CNS vasculitis, severe fibromuscular dysplasia, arteriovenous malformation, arteriovenous fistula, significant cervical or intracranial atherosclerotic stenotic disease (≥70%), or malignant brain tumor. 18. Uncontrollable hypertension (>180 systolic and/or >110 diastolic) that is not correctable prior to enrollment. 19. Known seizure or epilepsy disorder (diagnosed prior to this aSAH diagnosis) where anti-epileptic medication was previously taken by the patient or have been recommended to be taken by the patient. Childhood seizures that have resolved and no longer require treatment are not part of this exclusion criteria 20. Serious co-morbidities that could confound study results including but not limited to: Multiple Sclerosis, dementia, severe major depression, cancer likely to cause death in 2 years, multi-system organ failure, or any other conditions that could cause any degree of cognitive impairment. 21. Immunosuppression therapy including chronic corticosteroid usage. 22. Remote history of previous ruptured cerebral aneurysm. 23. History of gastrointestinal hemorrhage or major systemic hemorrhage within 30 days, hemoglobin less than 8 g/dL, INR ≥1.5, severe liver impairment (AST< ALT< AP 2 x normal or cirrhosis), creatinine > 2.0 mg/dL, or estimated GFR < 60 ml/min. 24. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days. 25. Currently pregnant. 26. Enrollment in another research study that would conflict with this study.
Drug: Continuous Low-Dose Intravenous Unfractionated Heparin Infusion (14 days)
Aneurysmal Subarachnoid Hemorrhage, Neurobehavioral Manifestations, Vasospasm, Intracranial, Intracranial Aneurysm, Heparin-induced Thrombocytopenia Type II
aneurysmal subarachnoid hemorrhage, unfractionated heparin, neurobehavioral manifestations, delayed ischemic neurological deficits, cerebral aneurysm, coil embolization, Montreal Cognitive Assessment
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Management of the PDA Trial (PDA)

Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
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Mambarambath Jaleel
85918
All
up to 21 Days old
Phase 3
This study is NOT accepting healthy volunteers
NCT03456336
STU-2019-0784
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Inclusion Criteria:

• Postnatal age 48 hours -21 days
• Infant 22 0/7 to 28 6/7 weeks gestation at birth
• sPDA, as defined as: 1. Mild, Moderate, or Severe Clinical Criteria with Small or Moderate size PDA on echocardiogram 2. Mild or Moderate Clinical Criteria with Large PDA on echocardiogram
Exclusion Criteria:

• Cardiopulmonary compromise
• Known congenital heart disease (besides atrial septal defect or ventricular septal defect)
• Known pulmonary malformation (e.g. congenital lobar emphysema, congenital pulmonary adenomatous malformation)
• Any condition which, in the opinion of the investigator, would preclude enrollment
Other: Active Treatment, Other: Expectant Management
Infant, Premature, Infant, Newborn, Diseases, Patent Ductus Arteriosus, Patent Ductus Arteriosus After Premature Birth, Heart
Parkland Health & Hospital System
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The Effects of Low Dose Ketamine on Cardiovascular Function

Low dose ketamine is used for pain management and for the treatment of anxiety and depression. Prior studies on low dose ketamine have noted short-term (minutes to hours) increases or decreases in blood pressure. Blood pressure that is too high or too low can be problematic if untreated. It is unknown exactly how low dose ketamine affects blood pressure. In fact, no prior studies have measured sympathetic nervous system activity after low dose ketamine has been given to an adult. Because sympathetic nervous system activity has a large influence on blood pressure, we need to know how exactly low dose ketamine affects these body systems. Therefore, in this research we will study how low dose ketamine affects sympathetic nervous system activity and cardiovascular function. The results from this research will inform doctors about how low dose ketamine affects the sympathetic nervous system, heart, and blood vessels.
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Craig Crandall
18601
All
18 Years to 45 Years old
Phase 1
This study is also accepting healthy volunteers
NCT04429685
STU-2019-1792
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Inclusion Criteria:

• Non-obese (body mass index less than 30 kg/m2) *alternatively, individuals will be permitted to participate if they have a body mass index value below 35 kg/m2 but a waist circumference below 88 cm for females and 102 cm for males
• Systolic blood pressure <140 mmHg
• Diastolic blood pressure <90 mmHg
Exclusion Criteria:

• Participants who have cardiac, respiratory, neurological, and/or metabolic illnesses
• Current or previous use of anti-hypertensive medications
• Any known history of renal or hepatic insufficiency/disease
• Pregnancy or breast feeding
• Current smokers, as well as individuals who regularly smoked within the past 3 years
• Individuals with a history of drug abuse
• Individuals who have an unexplained positive urine drug screen (e.g., some agents cause false-positive results, but when the agent is abstained for hours/days/weeks, the repeated drug screen is negative. One example could be an over-the-counter supplement)
Drug: Ketamine, Drug: Saline (placebo)
Healthy
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Cardiovascular Responses to Heat Waves in the Elderly

The purpose of this study is to assess the cardiovascular responses of the elderly to heat wave conditions
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Craig Crandall
18601
All
18 Years and over
This study is also accepting healthy volunteers
NCT04538144
STU-2019-1759
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Inclusion Criteria:

• Healthy male and female individuals
• 18-35 years or 65+ years of age
• Free of any underlying moderate to serious medical conditions
Exclusion Criteria:

• Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, uncontrolled hypertension, and uncontrolled hypercholesterolemia.
• Taking of any medications (such as beta blockers and non-dihydropyridine calcium channel blockers) that have known influences on either cardiac function or sweating responses.
• Abnormalities detected on routine screening.
• Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.
• Current smokers, as well as individuals who regularly smoked within the past 3 years.
• Body mass index of greater than 30 kg/m^2
• Pregnant individuals
Other: Simulated heat wave
Aging, Hyperthermia
aging, heat wave, cardiovascular
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COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis

Call 214-648-5005
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Sonja Stutzman
120434
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04650087
STU-2021-0233
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Inclusion Criteria:

• • Age ≥ 18 years
• PCR-positive COVID-19 infection
• Hospitalized for two or more days
Exclusion Criteria:

• Pre-existing indication for anticoagulation (e.g., pulmonary embolism or deep vein thrombosis; atrial fibrillation; mechanical cardiac valve)
• Contraindication to antithrombotic therapy (e.g., known bleeding within the last 30 days requiring emergency room presentation or hospitalization; major surgery within 14 days; ischemic stroke, intracranial bleed or neurosurgery within 3 months.
• Platelet count < 50,000/mcL
• Hemoglobin <8 gm/dL
• Renal insufficiency (eGFR < 30 mL/min/1.73 m2)
• Pregnancy
• Prison inmate
• Life expectancy less than 90 days
• Unwilling or unable to provide informed consent/unwilling or unable to complete the study protocol
• Dual antiplatelet therapy that cannot be discontinued
• Concomitant need for strong inducers/inhibitors of p-gp or CYP3A4
Drug: Apixaban 2.5 MG, Drug: Placebo
Cardiovascular, Covid19
UT Southwestern
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SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial (SMART)

studyfinder@utsouthwestern.edu
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04722250
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Inclusion Criteria:

• Heart Team agrees that the subject is deemed symptomatic and is a candidate for transcatheter aortic valve replacement (TAVR)
• Subject has a predicted risk of operative mortality < 15% as determined by the local Heart Team
• Subject has severe aortic stenosis as determined by transthoracic echocardiography (TTE) at rest
• Subject has a small aortic annulus as determined by Multi-detector computed tomography (MDCT)
• Subject's anatomy is appropriate for both Medtronic Evolut PRO/PRO+ TAV and Edwards SAPIEN 3/3 Ultra TAV
• Subject's anatomy is suitable for TAVR via transfemoral vessel access
• Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Exclusion Criteria:

• Estimated life expectancy of fewer than 2 years
• Multivessel coronary artery disease with a Syntax score >32 and/or unprotected left main coronary artery(Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned).
• Participating in another trial that may influence the outcome of this trial
• Need for an emergent procedure for any reason
• Contraindicated for treatment with the Evolut PRO/PRO+ and Edwards SAPIEN 3/3 Ultra TAV in accordance with the Instructions for Use
• Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
• Pregnant, nursing, or planning to be pregnant
• Subject is less than the legal age of consent, legally incompetent, unable to provide his/her own informed consent, or otherwise vulnerable
• Subject has an active COVID-19 infection or relevant history of COVID-19
• Previous aortic valve replacement
Device: Medtronic Evolut PRO or Evolut PRO+ TAV Systems, Device: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
Aortic Valve Stenosis, Symptomatic Aortic Stenosis, Aortic Valve Replacement
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Randomized On-X Anticoagulation Trial (PROACT)

Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.
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Michael Wait
17648
All
18 Years to 70 Years old
N/A
This study is NOT accepting healthy volunteers
NCT00291525
STU 072010-216
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Inclusion Criteria:

• Patients requiring isolated aortic valve replacement (AVR), or isolated mitral valve replacement (MVR).
• AVR patients receiving low dose or antiplatelet only anticoagulation will be divided into groups at low risk and high risk for thromboembolism with all patients being in the low risk group except for patients with the following conditions which place a patient in the high risk group:
• Chronic atrial fibrillation
• Left ventricular ejection fraction < 30 %
• Enlarged left atrium >50mm diameter
• Spontaneous echo contrasts in the left atrium
• Vascular pathology
• Neurological events
• Hypercoagulability
• Left or right ventricular aneurysm
• Lack of platelet response to aspirin or clopidogrel
• Women receiving estrogen replacement therapy
• Concomitant cardiac surgery is allowed
• Adult patients
Exclusion Criteria:

• Right side valve replacement
• Double (aortic plus mitral) valve replacement
• Patients with active endocarditis at the time of implant
• Previous confirmed or suspected thromboembolic event or thrombophlebitis
• Other terminal illness
• Patients who are in an emergency state
• Inability to return for required follow-ups
• Patients with an On-X valve implanted within the study and subsequently explanted
• Patients who are known to be pregnant, plan to become pregnant or are lactating
• Patients with acquired immunodeficiency syndrome or know to be HIV positive
• Patients who are prison inmates or known drug or alcohol abusers
• Patients unable to give adequate informed consent.
Device: On-X valve using reduced anticoagulation, Device: On-X Valve with Standard warfarin Therapy
Heart Valve Disease, Heart
valve, prosthesis, antithrombotics, randomized
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Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia

Funding Source - FDA OOPD This study is being done to find out whether an investigational (not approved by FDA ) drug called SLx-4090 or Orlistat (FDA approved medication for weight loss) when given alone or in combination can treat the high blood fat (elevated triglycerides)levels found in the condition Type 1 Hyperlipoproteinemia (T1HLP) better or more safely than low fat diet alone, the current standard medical care. It is also not clear whether Orlistat, that is FDA approved for weight loss, is effective in lowering blood fat levels in patients with Type 1 hyperlipoproteinemia (T1HLP). The researchers are interested in learning whether any one of these drugs when given alone or in combination is more effective and safe in treating T1HLP.
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Abhimanyu Garg
12461
All
12 Years to 100 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT01675154
STU 012013-042
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Inclusion Criteria:

• Type I hyperlipoproteinemia.
• Fasting serum triglyceride levels of greater than 1000 mg/dL.
• Age > 12 years
Exclusion Criteria:

• Secondary hypertriglyceridemias due to diabetes, renal disease, hypothyroidism, alcoholism and drug therapy such as estrogens and estrogen analogues, steroids, HIV-protease inhibitors, retinoic acid derivatives and interferons.
• Pregnant or lactating women
• Significant liver disease (elevated transaminases > 2 times upper limit of normal)
• Alcohol abuse (> 7 drinks or 84 g per week for women and > 14 drinks for men or 168 g per week for men)
• Drug use (cocaine, marijuana, LSD, etc.)
• Major surgery in the past three months
• Congestive heart failure
• Serum creatinine greater than 2.5 mg/dL
• Cancer within the past five years
• Gastrointestinal surgery in the past
• Current therapy with anti-coagulants, digoxin and anti-arrhythmics
• Chronic malabsorption syndromes
• Cholestasis
• Acute illnesses such as acute pancreatitis in the last 8 weeks
Drug: SLx-4090 placebo, Drug: Orlistat Placebo, Drug: Orlistat, Drug: Slx-4090
Type 1 Hyperlipoproteinemia, Other
hypertriglyceridemia
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Zenith® p-Branch® Endovascular Graft Pivotal Study

The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
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Carlos Timaran
68421
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02396199
STU 062015-095
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Inclusion Criteria:

• Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter
• Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year
• Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation
Exclusion Criteria:

• Age <18 years
• Life expectancy <2 years
• Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
• Inability or refusal to give informed consent by the patient or a legally authorized representative
• Unwilling or unable to comply with the follow-up schedule
• Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
• Additional medical restrictions as specified in the Clinical Investigation Plan
• Additional anatomical restrictions as specified in the Clinical Investigation Plan
Device: Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Aortic Aneurysm Abdominal, Cardiovascular
Abdominal aortic aneurysm, Endovascular, Juxtarenal, Pararenal, Fenestrated
UT Southwestern
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Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial (PAH)

This protocol describes an open-label phase 2 clinical trial of fluoxetine in PAH looking at change in pulmonary vascular resistance (PVR) as the primary endpoint. In this open-label clinical trial, 18 patients with pulmonary arterial hypertension will be given fluoxetine for 24 weeks. A Right Heart Catheterization will be performed at baseline and 24 weeks. Change in PVR will be the primary endpoint; other hemodynamic endpoints, quality of life, QIDS-SR depression scale, functional class and six-minute walk distance will also be evaluated. Primary Hypothesis: Fluoxetine treatment for 24 weeks will lead to significantly lower pulmonary vascular resistance in 18 patients with PAH in patients treated in an open-label clinical trial.
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Kelly Chin
38273
All
16 Years to 80 Years old
Phase 2
This study is also accepting healthy volunteers
NCT03638908
STU 082013-045
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Inclusion Criteria:
1. WHO Group I PAH subtypes of idiopathic PAH and PAH associated with drugs / toxins, connective tissue disease, repaired congenital heart disease and unrepaired atrial septal defect 2. Age 16-80 3. WHO Functional Class II or III 4. Right Heart Catheterization within 3 weeks of study entry with mPAP ≥ 25 mmHg, wedge ≤ 15 mmHg, and PVR ≥ 3 Wood units. 5. Contraception use, (-) urine pregnancy test, not breast feeding (women of childbearing potential) 6. One or more approved PAH therapies for ≥ 3 months, no change in dose for 1 month (endothelin-1 antagonist, phosphodiesterase-5 inhibitor, prostacyclin / prostacyclin analog). Novel approved therapies in one of the three existing classes will also be acceptable as background therapy if they become available during the course of the study; other medication classes are excluded
Exclusion Criteria:
7. WHO Functional Class IV or listed for lung transplant 8. Moderate or greater obstructive lung disease: FEV1/FVC <70% and FEV1 <60% 9. Moderate or greater restrictive lung disease: TLC or FVC <60% (if 50-60%: OK if TLC or FVC ≥50% + PFT stable x1 year + CT with no more than mild lung disease) 10. Other cause for pulmonary hypertension: all other WHO group I diseases (including but not limited to liver disease, HIV), and WHO Groups II-V (i.e. left heart disease, lung disease, chronic PE and miscellaneous causes)24. 1. High probability VQ or positive CTA 2. Left ventricular ejection fraction <40% 11. Depression 12. Severe liver, renal or other medical or physical disease preventing completion of the study procedures 13. Use of antidepressants within 3 months
Drug: Fluoxetine
Pulmonary Arterial Hypertension, Lung/Thoracic, Heart
UT Southwestern
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Lipoprotein(a) in Patients With Cardiovascular Disease (CVD)

The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).
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Parag Joshi
164267
All
18 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03887520
STU-2019-1656
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Inclusion Criteria:

• Signed informed consent
• Established CVD defined as one of the following:
• History of a myocardial infarction (MI) ≥3 months and ≤10 years before the study visit
• History of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit
• Symptomatic PAD (intermitted claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or re-vascularization due to lower limb ischemia
Exclusion Criteria:

•Patients currently enrolled in clinical studies with investigational drugs
Diagnostic Test: Blood draw for Lp(a)
Cardiovascular Disease and Lipoprotein(a)
CVD, Lipoprotein (a),
UT Southwestern
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Sympathetic Transduction in Obesity-associated Hypertension (OB-HTN) (OB-HTN)

Christopher M Hearon, Ph.D. christopher.hearon@utsouthwestern.edu
All
30 Years to 55 Years old
Early Phase 1
This study is also accepting healthy volunteers
NCT04838678
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Inclusion Criteria:

• Control
•BMI<30, age 30-55
• Hypertensive
•BMI<30, age 30-55, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring Obese- BMI>30, age 18-70 Obese-hypertensive- BMI>30, age 30-55, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring
Exclusion Criteria:
All groups
•presence of other significant cardiovascular disease, renal disease, history of smoking, diabetes,
Drug: Neuropeptide Y
Obesity, Hypertension
NPY
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Impact of Empagliflozin on Functional Capacity in Heart Failure With Preserved Ejection Fraction

James Macnamara, MD James.macnamara@utsouthwestern.edu
James Macnamara james.macnamara@utsouthwestern.edu
All
50 Years to 85 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05139472
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Inclusion Criteria:

• adults ages 50-85, type 2 diabetes mellitus, and clinical heart failure with ejection fraction > 50%
Exclusion Criteria:

• previous hypersensitivity or adverse reaction to SGLT-2 inhibitors, currently treated with SGLT-2 inhibitor, ejection fraction <50%, chronic kidney disease with glomerular filtration rate < 45 ml/kg/min, unstable coronary artery disease, significant arrhythmia, BMI >55 kg/m2 and inability to exercise.
Drug: Empagliflozin 10 MG
Heart Failure With Preserved Ejection Fraction, Diabetes Mellitus, Heart Failure, Diastolic
Exercise, Invasive Exercise Testing, SGLT-2 Inhibitors
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Analysis of Cerebral Perfusion Using Head Ultrasound and Multisource Detector Near Infrared Spectroscopy (NIRS) Imaging

The purpose of this study is to use an experimental diagnostic tool(NIRS), combined with a known screening tool (cranial ultrasound), to analyze and evaluate cerebral blood flow and oxygenation, and determine if abnormal neurodevelopmental outcomes can be predicted and potentially improved upon in pediatric patients undergoing repair for congenital heart disease.
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Lakshmi Raman
102213
All
up to 2 Months old
N/A
This study is NOT accepting healthy volunteers
NCT01082536
STU 042013-099
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Inclusion Criteria:
1. Is less than 2 months of age 2. Has congenital heart disease requiring surgical repair. 3. All racial and ethnic groups will be eligible. Both genders are eligible. 4. Spanish-speaking subjects are eligible.
Exclusion Criteria:

• Patients with known genetic syndromes will be excluded from the study.
Congenital Heart Disease
Pediatrics, Congenital heart disease, NIRS, Brain oxygenation
Children’s Health
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Covered CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta (COASTII)

Coarctation of the aorta (CoA) is a congenital abnormality producing obstruction to blood flow through the aorta. Coarctation can occur in isolation, in association with bicuspid aortic valve or with major cardiac malformations. CoA accounts for 5-8% of the 8/1000 (4-6/10,000) children born with congenital heart disease. Most CoA is newly diagnosed in childhood; < 25% recognized beyond 10 yrs. CoA is mostly repaired in childhood by surgery or by balloon catheter dilation. Recurrence rates range from 5-20%. Recurrence is often not recognized until adolescence. Balloon expandable stents have become the predominant therapy in the USA and Europe for CoA treatment in this age group. There are no FDA approved stents for this use. Biliary stents are currently being used off label. Enrollment into a trial of bare metal Cheatham Platinum (CP) Stents, designed for use in CoA, is completed. The Coarctation of the Aorta Stent Trial (COAST) aims to confirm safety and efficacy of CP Stent for native and recurrent CoA. There are CoA patients with clinical situations that place them at high risk of aortic wall injury during bare metal stenting. Extreme narrowing, genetic aortic wall weakness and advanced age are examples. Patients may present with aortic wall injury (aneurysm) related to prior CoA repair. The occurrence after surgical repair is 3-4% and after balloon dilation 10-20%. Repair of these aneurysms is surgically challenging. The use of fabric-covered CP Stents to prevent or repair aortic wall injury has become the treatment of choice in Europe and recently in the US through the FDA Compassionate Use process. There are no alternative devices available in the US. COAST II will test safety and efficacy of Covered CP Stents to repair or prevent aortic wall injury associated with CoA. Funding Source-FDA OOPD
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Thomas Zellers
18301
All
Not specified
Phase 2
This study is NOT accepting healthy volunteers
NCT01278303
STU 092010-211
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Inclusion Criteria:
Inclusion criteria for use of a Covered CP Stent: Native or recurrent aortic coarctation*associated with ONE OR MORE of the following: 1. Acute or chronic aortic wall injury, or 2. Nearly atretic descending aorta to 3 mm or less in diameter, or 3. Genetic Syndromes associated with aortic wall weakening. Individuals with genetic syndromes such as Marfan Syndrome, Turner's Syndrome or familial bicuspid aortic valve and ascending aortic aneurysm, or 4. Advanced age. Men and woman aged 60 years or older.
• The significance of aortic obstruction is left to the judgment of the participating investigator. indications might include mild resting aortic obstruction associated with: Exercise related upper extremity hypertension; Severe coarctation with multiple and/or large arterial collaterals; Single ventricle physiology Left ventricular dysfunction Ascending aortic aneurysm + Aortic wall injury might include: Descending aortic aneurysm Descending aortic pseudo-aneurysm Contained aortic wall rupture Non-contained rupture of the aortic wall
Exclusion Criteria:
1. Patient size too small for safe delivery of the device. The absolute lower limit for inclusion under this protocol is 20 kg. However, serious femoral artery injury can occur in small patients, particularly those in the 20-30 kg range and this risk must be reviewed in detail with parents or guardians of children in this weight range. 2. Planned deployment diameter less than 10 mm or greater than 22 mm 3. Location requiring covered stent placement across a carotid artery* 4. Adults lacking capacity to consent 5. Pregnancy
• crossing or covering of a subclavian artery is acceptable in certain situations, but only after alternative treatments have been considered.
Device: Treatment of Aortic Wall Injury
Aortic Coarctation
Coarctation, Aorta
Children’s Health
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Multicenter Trial of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent (ALTERRA)

To demonstrate the safety and functionality of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR).
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Thomas Zellers
18301
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT03130777
STU 082017-081
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Inclusion Criteria:
1. The patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. 2. Pediatric or adult patent whose weight is ≥ 20 kg (44 lbs). 3. The patient has a dysfunctional RVOT/PV. 4. RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm and/or minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff immediately prior to Alterra Prestent insertion.
Exclusion Criteria:
1. Active infection requiring current antibiotic therapy (if temporary illness, patient may be a candidate 2 weeks after discontinuation of antibiotics). 2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days. 3. Leukopenia (WBC < 2000 cells/μL), anemia (Hgb < 7 g/dL), thrombocytopenia (platelets < 50,000 cells/μL) or any known blood clotting disorder. 4. Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV.
Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
Pulmonary Disease, Congenital Heart Disease, Transpulmonary Valve Replacement, Pulmonary Stenosis, TPVR, Tetralogy of Fallot
Children’s Health
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Physiological Study of the Efficacy and Mechanistic Effects of Alcohol Renal Denervation

Hypertension is a major risk factor for heart disease and stroke, two of the leading causes of death in the United States. Hypertension is a common and widespread problem; unfortunately, current treatment strategies fail to adequately control blood pressure in up to 50% of patients either because of failure to take prescribed medications (because of cost, side effects, inconvenience etc.) or lack of therapeutic response. Indeed, it is estimated that 50% of patients stop taking antihypertensive medication within 6-12 months after the initiation of drug therapy. Despite enthusiasm for a novel approach called renal denercation, presently there are no integrative studies of the antihypertensive effect of renal denervation on the multiple regulatory pathways it may consequentially affect. Experimental evidence from pre-clinical models suggests the effects are due to reducing efferent sympathetic activity and thus lowering blood pressure by altering the renin-angiotensin system. Uncontrolled clinical studies in humans suggest that when effective, this procedure may also lower renal sympathetic nerve activity. However the sympathetic response to monopolar radiofrequency therapy has been highly variable. Moreover, there have been no assessments of procedural efficacy performed in humans. Thus the actual mechanism by which this type of procedure reduces BP in humans is largely unknown, making it extremely difficult to identify the appropriate patients for this invasive procedure. Recently, chemical renal denervation using ethanol (EtOH), was demonstrated to markedly lower blood pressure in small numbers of patients with resistant hypertension. However the mechanisms by which blood pressure is altered using this novel technique in humans is entirely unknown, and procedural efficacy has also not been assessed. Therefore it is unclear, whether in humans renal sympathetic nerve activity is lowered following renal denervation using this new approach. The Investigators propose to use high resolution physiological testing to determine the effects of chemical renal artery denervation on sympathetic activity. Therefore the global objective of this physiological study is to provide the first detailed assessment of the integrated mechanistic effects of chemical renal nerve denervation in humans with hypertension that is uncontrolled by conventional treatment (because of lack of adherence or response to therapy).
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Benjamin Levine
14262
All
18 Years to 75 Years old
Early Phase 1
This study is NOT accepting healthy volunteers
NCT03465917
STU 112014-023
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9.1 Please indicate the inclusion criteria for enrollment: Six patients will participate in this study. Patients who present with uncontrolled hypertension (classified as clinic systolic blood pressure not at target level >140mmHg) to their primary care provider, emergency room (ER), specialist hypertension clinic or urgent care center will be asked to participate. Inclusion criteria include: 1. Patient presents with treated or untreated hypertension. 2. Adults aged 18-75 years, male or female 3. Patient has a clinic systolic blood pressure >140mmHg (average of 3 measurements), or >135mmHg in patients with type II diabetes 4. Patient has a daytime mean systolic blood pressure of ≥135 and diastolic blood pressure ≥85mHg based on 24 hours ambulatory blood pressure monitoring 5. Investigator judges that the subject can be managed safely for up to 12 weeks (4 weeks run-in plus 8 weeks post-treatment) with the use of standard background regimen of losartan/hydrochlorothiazide; patients with true resistant hypertension will be required to maintaining current antihypertensive regime for the duration of the study. Exclusion Criteria. Any patient who meets any of the following exclusion criteria will not be eligible for the study. 1. Patient has known or suspected secondary hypertension 2. Use of systemic drugs that may be used for the treatment of hypertension, for a non-hypertension indication for the trial, (e.g. atrial fibrillation/atrial flutter, heart failure, or calcium channel blocker for heart rate control). 3. Renal artery stenosis ≥ 50% diameter stenosis, or aneurysm(s) 4. Patients with atrial fibrillation. 5. Patient has type 1 diabetes 6. Patient has type 2 diabetes and evidence of peripheral neuropathy 7. History of previous stenting or balloon angioplasty of the renal arteries. 8. Untreated hypothyroid or hypo-parathyroid. 9. Orthostatic hypotension defined as >20 mmHg of systolic blood pressure and/or more than 10 mmHg in diastolic blood pressure fall after standing for 3mins 10. Renal artery anatomy as assessed by imaging (CT-angiogram or, MR angiogram or renal angiogram) meeting the following criteria: 1. Single renal artery or two renal arteries, if either has a diameter of < 5 mm or > 7 mm or a length of < 11 mm, 2. Accessory renal arteries with diameter > 2.0 mm and < 5.0 mm, 3. Excessive renal artery tortuosity based on Investigator judgment, 4. Moderate or severe, and diffuse renal artery calcification, and/or 5. Renal anatomic renovascular abnormalities (as assessed by renal imaging) that would increase the risk of renal catheterization. 11. Occlusive peripheral vascular disease that would preclude percutaneous access for the procedure. 12. Patient is known to have a unilateral non-functioning kidney or unequal renal size (> 2cm difference in renal length between kidneys). 13. Single kidney, kidney tumor, urinary tract obstruction, or other anatomic abnormality. Note: Simple renal cysts are not an exclusion. 14. Previous renal denervation. 15. History of renal transplantation. 16. Estimated eGFR (by the CKD-Epi formula) ≤45 mL/min per 1.73 m2, or on chronic renal replacement therapy. Patients with eGFR of <60 mL/min per 1.73 m2 will undergo additional renal function monitoring post procedure and/or contrast exsposure. 17. Unexplained hypokalemia (i.e. K < 3.5 mEq/L in patients not on a potassium-wasting diuretic). 18. Patient in whom an ABPM device cannot be used due to arm size (>50 cm arm circumference) or other reasons as identified by the Investigator or study coordinator. 19. Patient with severe cardiac valve stenosis for which, in the opinion of the Investigator, a significant reduction of blood pressure is contraindicated. 20. Heart failure greater than asymptomatic, New York Heart Association Functional Classification, class I, stage B heart failure 21. Patient with history of myocardial infarction, unstable angina pectoris, or stroke during the 6 months prior to screening 22. Known primary or secondary pulmonary hypertension. 23. Active infection. 24. Patient requiring chronic oxygen support or has severe COPD. 25. Patient has known hypersensitivity to contrast agents that cannot be adequately pre-medicated 26. A known hypersensitivity to Dehydrated Alcohol Injection. 27. Platelet count < 75,000/microliter and/or known bleeding diathesis or coagulopathy at time of screening. 28. Receiving anticoagulant drugs (e.g., warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, or low molecular weight heparins), that in the opinion of the investigator, would affect the safety of the trial procedure. Use of antiplatelet drugs such as aspirin and/or thienopyridines (e.g., clopidogrel) are permitted. 29. Patient has current problems with substance abuse (e.g. alcohol, illegal drugs, etc.). 30. Patient on high dose of steroids or immunosuppressant therapy. 31. Patient has a history of myocardial infarction, unstable angina pectoris, or stroke during the 3 months prior to screening. 32. Patients with a history of pre-eclampsia 33. patients with fibromuscular dysplasia 34. patients with history of pyelonephritis within 6 months 35. patients with history of recurrent (> one episode) kidney stones or history of kidney stones within the last year 36. Pregnant or nursing or planning to become pregnant during the trial time period. Note: If subject is of childbearing potential, as defined in the protocol, agrees to use of contraception. 37. Any acute or chronic condition that the investigator believes will adversely affect the ability to interpret the data or will prevent the subject from completing the trial procedures, or has a life expectancy of < 12 months.
Combination Product: Renal Denervation
Hypertension
UT Southwestern
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Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial (SIT)

The goal of this study is to determine the effectiveness of blood transfusion therapy for prevention of silent cerebral infarct (stroke) in children with sickle cell anemia.
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Patrick Leavey
35610
All
5 Years to 14 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT00072761
Study00000074
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INCLUSION:
• Patient must have sickle cell anemia (hemoglobin SS) or sickle beta thalassemia (hemoglobin SB) as confirmed at the local institution.
• Participating institutions must submit documentation of the diagnostic hemoglobin analysis to the Statistical and Clinical Coordinating Centers to confirm the diagnosis of sickle cell anemia prior to randomization.
• Patient must be 5 through 14 years of age.
• Patient must have a cerebral infarct documented by MRI scan as read by the neuroradiology panel.
• Informed consent with assent in accordance with the institutional policies (institutional Institutional Review Board approval) and Federal guidelines (approved by the United States Department of Health and Human Services) must be signed by the patient's legally authorized guardian acknowledging written consent to join the study. When suitable, patients will be requested to give their assent to join the study. EXCLUSION:
• Patient with a history of a focal neurologic event lasting more than 24 hours with medical documentation or a history of prior overt stroke.
• Patients with a transcranial doppler (TCD) study with a time-averaged mean velocity greater than 200 cm/sec verified by the study radiologist.
• Patients with other neurological problems, such as neurofibromatosis, lead poisoning, or tuberous sclerosis.
• Patients with HIV infection.
• Pregnancy.
• Patients who received treatment with anti-sickling drugs or hydroxyurea within 3 months or anticipate receiving anti-sickling drugs or hydroxyurea during the course of the study.
• Abnormal kidney function (creatinine > 2x upper limit of normal).
• Patients on chronic blood transfusion therapy for other reasons.
• Patients judged not likely to be compliant by his/her hematologist and local nurse coordinator based on previous compliance in clinic appointments and following advice. Specifically, families that have missed at least two appointments without notification within 12 months prior to the trial or parents of potential patients that have been reported for medical or education neglect are not eligible for this trial.
• Patients unable to receive blood transfusion because of alloimmunization.
• Patients with permanent or semi-permanent metallic (braces on teeth) structures attached to their body. Such patients cannot obtain a MRI of the head to assess the presence of silent cerebral infarcts.
• Siblings randomized in the trial.
Procedure: transfusion therapy
Stroke, Sickle Cell Anemia
silent cerebral infarct, silent stroke, sickle cell anemia, stroke, transfusion therapy
Children’s Health
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FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease

This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.
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Ayesha Zia
149180
All
8 Years to 21 Years old
This study is NOT accepting healthy volunteers
NCT04583878
STU-2020-0868
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Inclusion Criteria:

• Ages 8 to ≤ 21 years
• Participant must be able to speak and understand English
• Be willing to participate and able to comply with the study protocol
• For participants with PE: Children with acute, radiologically confirmed pulmonary embolism (PE) with our without DVT
• For control group: Children who are prescribed physical activity restrictions for 4 up to 12 weeks following any minor outpatient surgery or, minor injury (surgery or injury is referred to as "diagnosis" hereafter)
Exclusion Criteria:

• Congenital heart disease with abnormal pulmonary circulation or with in-situ pulmonary artery thrombosis
• Chronic kidney disease
• Chronic inflammatory or an autoimmune disorder (such as systemic lupus erythematosus, juvenile rheumatoid disorder, inflammatory bowel disease, and sickle cell disease)
• A metabolic or endocrinological disorder such as diabetes mellitus or thyroid disorder
• History of or active cancer
• Pregnant
• Musculoskeletal limitations to exercise expected to be present uptil 4 months post-diagnosis
• Weight ≥ 300 lbs
• Contraindications to magnetic resonance imaging
• Frequent severe exacerbations of asthma defined by two or more bursts of systemic glucocorticoids (more than three days each) in the previous year or at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous year. Patients should also be excluded if there are daily symptoms of asthma requiring daily use of short-acting bronchodilators such as albuterol or levalbuterol administration. The use of controller medications such as daily inhaled corticosteroids for mild persistent asthma is not exclusionary.
• Has any other medical condition, which in the opinion of the investigator may potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical study Additional exclusion criteria for participants with PE:
• Prior history of DVT or PE (upper extremity, cerebral sinus venous thrombosis and abdominal thromboses encountered as a neonate are not exclusion criteria)
• Lack of anticoagulant treatment for the acute VTE due to contraindications
Diagnostic Test: Blood draw (Visit 1), Diagnostic Test: Blood draw (Visits 2 and 3)
Pulmonary Embolism, Deep Venous Thrombosis, Cardiovascular, Lung/Thoracic
Children’s Health
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Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Patients With Subacute Stroke

This will be a double blinded randomized clinical trial carried out at Zale-Lipshy and Parkland Hospital Inpatient Rehabilitation Facilities. Acute stroke patients with insomnia, identified by the Insomnia Severity Index (ISI), and who choose to participate in this study will be randomized to CES (Cranial Electrical Stimulation) or sham CES. Patients who do not feel they are getting adequate sleep but want to continue in the study will be given the option to receive the standard of care medication as a rescue starting on the 3rd night. Patients will receive treatment with a Fisher-Wallace CES device or Sham CES. Treatment with CES will be for 20 minutes once a day, and the treatment period will be for 7 days. Patients will be allowed to increase the intensity of the device from the suggested starting point of level 2 if they feel no improvement in sleep on night 1. Groups will be monitored with a wrist worn actigraph that records the patient's activity for the duration of the period of study and provides data on sleep latency, time spent asleep, and sleep efficiency. The outcome measures will be total minutes/hours of sleep, sleep efficiency and subjective reports of drowsiness using the Karolinska Sleepiness Scale. Actigraphic data will be collected 24 hours a day for 7 days. The total length of study will be about 24 months with a target N of 100 consented individuals and 85 participants. Patients will be allowed to exit the study at any time on their own choosing. To minimize loss of subjects, patients will have the option to choose SOC rescue starting on the third night. Patients who choose the SOC rescue will continue to be monitored with an actigraph for data collection purposes. The investigator should discontinue study participation for a given subject or withdraw the subject from study if he/she believes that continuation would be detrimental to the subject's well-being. A subject can decide to withdraw from the study at any time and for any reason.
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Amy Mathews
173575
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03344562
STU 072016-005
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Inclusion Criteria:
1. Written informed consent must be obtained. 2. Patients must be admitted to inpatient rehab. 3. Patients must have a documented acute stroke (ischemic, hemorrhagic or embolic). 4. Patients must have at least one fully functional arm which can be used to record actigraph data via a wrist worn actigraph device. 5. Subjects must Score a 7 or higher on the ISI. 6. Patients must be able to communicate consent and/or desire to discontinue the study. Exclusion Criteria 1. Demand or sensing type cardiac pacemaker. 2. Known uncontrolled seizure disorder. 3. Current history of vertigo. 4. Need for continuous O2. 5. Inability to communicate or provide consent. 6. Restricted use or absence of both arms. -
Device: CES, Device: CES
Cerebrovascular Accident, Sleep Disorder
Parkland Health & Hospital System
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Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms (SCENT)

This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left untreated, the bulge may continue to grow larger and ultimately the vessel may break open (rupture), resulting in serious bleeding into or around the brain. The information collected from this study will be used to evaluate how well patients do when treated with the Surpass System both immediately after treatment of an aneurysm and over a long period of time (5 years).
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Babu Welch
67812
All
19 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01716117
STU 112012-010
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Inclusion Criteria:

• Age 19 to 80 years
• Subject or legal representative is willing and able to give informed consent
• Subject has a single targeted intracranial aneurysm
• Subject agrees to return to the treating Investigator for all scheduled follow up visits and is capable of returning to the hospital for follow up
Exclusion Criteria:

• Known allergy or contraindication to aspirin, clopidogrel/Plavix, heparin, local or general anesthesia
• Known history of life threatening allergy to contrast dye
• Known allergy to nickel, chromium cobalt, tungsten or platinum
• Subject has documented resistance to clopidogrel/Plavix
• Major surgery within previous 30 days or planned in the next 120 days after enrollment date
• Previous intracranial implant associated with the symptomatic distribution within the past 12 weeks prior to treatment date
• Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment date
• Any previous stenting of parent artery at or proximal to the aneurym where it would interfere with the placement and proper apposition of the device
• Any previous coiling where it would interfere with the placement and proper apposition of the device
• Platelet count less than 100,000 cells/mm3 or known platelet dysfunction
• More than one intracranial aneurysm (IA) that requires treatment within 12 months
• Asymptomatic extradural aneurysms requiring treatment
• Contraindication to CT scan or MRI
• Severe neurological deficit that renders the subject incapable of living independently
• Unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days)
• Evidence of active infection at the time of treatment
• Dementia or psychiatric problem that prevents the patient from completing required follow up
• Co-morbid conditions that may limit survival to less than 24 months
• Serum creatinine greater or equal to 2.5 mg/dL
• Female subjects who are pregnant or planning to become pregnant within the study period
• Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis
• Extra-cranial stenosis or parent vessel with stenosis greater than 50% in the area proximal to the aneurysm
• Other known serious concurrent medical conditions
• History of intracranial vasospasm not responsive to medical therapy
• Subject with an intracranial mass, or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
• Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions
• Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date
• Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
• Inability to understand the study or a history of non-compliance with medical advice
• Current use of illicit substance
• Enrollment in another trial involving an investigational product
• Subject has a need for long-term use of anticoagulants (i.e., Warfarin, Dabigatran)
Device: Surpass Flow Diverter
Brain Aneurysm, Brain and Nervous System
Large aneurysm, Giant aneurysm, Wide neck aneurysm
UT Southwestern
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Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)

The Intermacs registry is a national quality improvement system designed to advance the understanding and application of mechanical circulatory support in order to improve the duration and quality of life in patients with advanced heart failure.
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Matthias Peltz
19035
All
Not specified
This study is NOT accepting healthy volunteers
NCT00119834
STU 082010-019
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Inclusion Criteria:

• Legally utilized MCSD implanted on or after March 1, 2006; every consented patient who receives an eligible MCSD at a participating center will be enrolled, regardless of reason (i.e., bridge-to-recovery, bridge-to-alternative bridge, bridge-to-clinical improvement for transplant eligibility, bridge-to-transplant, destination therapy). Beginning June 1, 2014, and with lnstitutional Review Board approval, participating sites may enroll patients under a waiver of informed consent and authorization.
• Eligible devices include all of the following: 1) approved devices for any indications; 2) Intermacs-linked trial of investigational device or approved device for investigational indications, for which data will be entered via the Intermacs framework; 3) external trial of investigational device or approved device for investigational indications, for which data will be collected by an external group; 4) compassionate use of investigational devices or approved devices outside of approved indications or clinical trials
Exclusion Criteria:

• Currently incarcerated
Device: Mechanical Circulatory Support Device (MCSD)
Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive, Heart
Heart Failure, Intermacs, Pedimacs, Mechanical Circulatory Support, Ventricular Assist Device
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Precision Event Monitoring for Patients With Heart Failure Using HeartLogic (PREEMPT-HF)

The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study. Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.
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James Daniels
46951
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT03579641
STU 072018-065
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Inclusion Criteria:

• Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws.
• Subject has a documented diagnosis of heart failure.
• Subject has a Boston Scientific Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator device implant that has HeartLogic, with Heart Failure Sensors turned ON, Respiratory Sensor turned ON, and Sleep Incline Sensor turned ON.
• Subject has an active bipolar right ventricle lead implant.
• Subject is enrolled in LATITUDE (NXT 5.0 or future version), and is willing to be remotely monitored from the baseline visit for approximately 12 months with HeartLogic disabled.
Exclusion Criteria:

• Subject has received or is scheduled to receive a heart transplant or ventricular assist device (VAD).
• Subject is enrolled in any concurrent clinical study without prior Boston Scientific written approval (excluding registries).
• Subject has a life expectancy of less than 12 months.
• Subject has a history of non-compliance to medical care or known inability to comply with requirements of the clinical study protocol
Device: HeartLogic Sensors
Heart Failure, Heart Disease, Cardiovascular Disease, Defibrillators, Implantable, Monitoring, Physiologic, Cardiac Resynchronization Therapy
Heart Failure, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Defibrillator, Heart Failure Sensor Data, 30-day Heart Failure Readmission, Ventricular Tachycardia/Ventricular Fibrillation Therapy, Non-Heart Failure Hospitalization, HeartLogic Feature, Latitude Remote Patient Monitor, Data Linkage, Sleep Incline Sensor, Respiratory Sensor, Decongestive Intravenous therapy, Decompensation
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Aging and Disease Course: Contributions to Lifespan Neurobiology of Schizophrenia

The 2020 NIMH Strategic Plan for Research calls for investigations targeting neurobiology of mental illness across the lifespan. Growing evidence suggests that lifespan neurobiology of schizophrenia (SZ) incorporates two distinct dimensions: aging and disease course. However, their clinical correlates, associated biomarker trajectories, and implications for treatment are unknown. This study will investigate differential aspects of SZ neurobiology captured by aging and disease course, in order to develop specific biomarkers which may offer actionable targets for SZ stage-dependent intervention. The study is predicated on a novel mechanistic Model of SZ Trajectories across the Adult Lifespan, positing distinct biological fingerprints within the anterior limbic system for aging and disease course in SZ: (1) alterations in the circuit's function and structure that occur earlier in the lifespan and are larger in magnitude than the alterations expected with normal aging (accelerated aging dimension); and (2) regionally-specific anterior limbic "hyperactivity" in early SZ, with a subsequent transformation into "hypoactivity" in advanced SZ (disease course dimension). In a sample of SZ and matched healthy controls (n=168, 84/group) aged 18-75 years the investigators will ascertain a broad panel of biomarkers [via multimodal brain imaging: optimized 1H-MRS, high-resolution task-based fMRI, perfusion (Vascular Space Occupancy) and structural MRI], along with comprehensive cognitive and clinical assessments. All measures will be acquired at baseline and repeated at 2-year longitudinal follow-up. Using cutting-edge computational approaches, the study will examine (i) effects of aging and SZ course on anterior limbic system biomarkers; (ii) lifespan trajectories for different biomarkers; (iii) patterns of limbic system biomarkers in age- and SZ course-based subgroups (e.g., Younger vs. Older, Early-Course vs. Advanced SZ), as well as in data-driven subgroups (e.g., those with vs. without accelerated aging profiles); and (iv) associations between biomarkers and cognitive and clinical outcomes. This research will advance the field by providing novel biomarkers that capture unique neurobiological contributions of aging and disease course in SZ, and will motivate future studies on SZ mechanisms across the lifespan and development of precision treatments.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Elena Ivleva
70523
All
18 Years to 75 Years old
This study is also accepting healthy volunteers
NCT04951700
STU-2021-0413
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Inclusion Criteria:

• 18-65 years of age (SZ); 18-75 years of age (CON)
• Women and men
• All races and ethnicities
• Psychiatric diagnoses: Patient participants (SZ): Meet DSM-5 criteria for schizophrenia or schizoaffective disorder Healthy control participants (CON): No personal history of lifetime psychiatric disorders, or a family history of psychotic disorders in 1st-or 2nd- degree relatives
• Able to read, speak, and understand English
• Able and willing to provide written informed consent; and willing to commit to the study protocol, including 2-year longitudinal follow-up
Exclusion Criteria:
• Compromised cognitive function: Both SZ and CON participants: Estimated premorbid intellectual ability <75 age-corrected score on Wide Range Achievement Test-4/Word Reading Subtest (WRAT-4) CON participants: <26 score on the Montreal Cognitive Assessment (MoCA)
• Neurological or medical disorder that may affect brain function (history of stroke, head injury with a loss of consciousness >10 min, seizure disorder, AIDS, poorly controlled hypertension, poorly controlled diabetes, decompensated lung disease, etc.)
• Co-morbid DSM-5 diagnosis of drug/alcohol use disorder in prior 3 months
• Current treatment with benzodiazepine or non-benzodiazepine sedatives/hypnotics, and/or anticonvulsants
• Presence of ferromagnetic objects in body
• Weight or body size exceeding MRI scanner capacity [>300 lbs]
• Claustrophobia in MRI scanner
• Pregnant women
• Breastfeeding women (VASO scan will not be administered. All other imaging modalities are safe to administer.)
• Impaired kidney function: Glomerular Filtration Rate (GFR) < 30 ml/min/1.73m2 (VASO scan will not be administered due to an association between Gadolinium-based MR contrast use and Nephrogenic Systemic Fibrosis in individuals with severely impaired renal function. All other imaging modalities are safe to administer.)
• History of hypersensitivity to any MRI contrast agent (VASO scan will not be administered. All other imaging modalities are safe to administer.)
Other: Other
Schizophrenia, Aging, Disease Course, Biomarker, Neuroimaging, Cognitive Dysfunction
UT Southwestern
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Effects of Obesity in the Aged

studyfinder@utsouthwestern.edu
All
65 Years to 75 Years old
This study is also accepting healthy volunteers
NCT05028309
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Inclusion Criteria:

• Otherwise healthy older adults 65-75 years of age with normal lung function; men 30< %body fat ≤50 and women 35< %body fat ≤55; and ability to perform pulmonary and exercise test. Other inclusion criteria include the following:
• Nonsmokers who have no history of smoking
• No personal history of significant mental illness
• No weight loss dietary restrictions
• No current or past history of significant substance or alcohol abuse
• No history, evidence, or uncontrolled symptoms of heart disease
• No history of uncontrolled hypertension
• No current medications that may interfere with exercise capacity
• No recent history or indication of asthma
• No musculoskeletal abnormality that would preclude exercise
• No documented sleep disorders (e.g., SDB &/or sleep apnea)
• No serious health conditions that would preclude study goals or participation in exercise (per PI & medical staff & preliminary or follow up testing; including significant other diseases, occult asthma, prior surgeries-especial lung or abdominal, or history of chemotherapy that could affect lung or heart function)
• No metabolic disorders (e.g., diabetes).
• Only postmenopausal women will be included.
• Women on hormone replacement therapy will be allowed to participate if the dosage remains similar during the entire protocol.
Exclusion Criteria:

• Volunteers with a mMRC score of 3 or 4 will be excluded due to likeliness of underlying disease.
• Individuals participating in regular vigorous conditioning exercise such as running, jogging, aerobics, cycling, or swimming more than two times per week will be excluded. However, if subjects have an exceedingly high exercise capacity (greater than 2 SD of predicted), they will be excluded.
• Maximal cycle ergometry test will be used to determine if further participation in testing is appropriate for the participant (e.g., normal exercise test, exclude presence of provokable ECG changes suggestive of heart disease, or dangerous arrhythmias or exercise induced hypertension or bronchoconstriction. If the participant develops an abnormal ECG or shows other signs of exercise intolerance or if signs of cardiovascular disease are noted during the exercise test, it will be terminated and the participant will be referred to their personal physician for further evaluation (see DMSP).
• Premenopausal women will be excluded.
Obesity, Aging
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EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)

studyfinder@utsouthwestern.edu
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04509674
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Inclusion Criteria:
1. Of full age of consent (according to local legislation, at least ≥ 18 years) at screening. 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. 4. Diagnosis of acute Myocardial Infarction (MI) (type 1 per the Universal Definition of Myocardial Infarction): ST-Elevation Myocardial Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (NSTEMI) with randomisation to occur no later than 14 calendar days after hospital admission. For patients with an in-hospital MI as qualifying event, randomization must still occur within 14 days of hospital admission. 5. High risk of HF, defined as EITHER 1. Symptoms (e.g. dyspnea; decreased exercise tolerance; fatigue), or signs of congestion (e.g. pulmonary rales, crackles or crepitations; elevated jugular venous pressure; congestion on chest X-ray), that require treatment (e.g. augmentation or initiation of oral diuretic therapy; i.v. diuretic therapy; i.v. vasoactive agent; mechanical intervention etc.) at any time during the hospitalization. OR 2. Newly developed Left Ventricular Ejection Fraction (LVEF) < 45% as measured by echocardiography, ventriculography, cardiac Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or radionuclide imaging during index hospitalisation. 6. In addition at least one of the following risk factors:
• Age > 65 years,
• Newly developed LVEF < 35%,
• Prior MI (before index MI) documented in medical records,
• Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2 (using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI) formula based on creatinine from local lab at any time during index hospitalisation),
• Atrial fibrillation (persistent or permanent ; if paroxysmal, only valid if associated with index MI),
• Type 2 diabetes mellitus (prior or new diagnosis),
• N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) >1,400 pg/mL for patients in sinus rhythm, >2,800 pg/mL if atrial fibrillation; Brain Natriuretic Peptide (BNP) >350 pg/mL for patients in sinus rhythm, >700 pg/mL if atrial fibrillation, measured at any time during hospitalisation,
• Uric acid >7.5 mg/dL (>446 μmol/L), measured at any time during hospitalisation,
• Pulmonary Artery Systolic Pressure >40 mmHg (non-invasive [usually obtained from clinically indicated post-MI echocardiography] or invasive, at any time during hospitalisation),
• Patient not revascularized (and no planned revascularization) for the index MI (Includes e.g. patients where no angiography is performed, unsuccessful revascularization attempts, diffuse atherosclerosis not amenable for intervention; but does NOT include if revascularization was not performed due to nonobstructive coronary arteries),
• 3-vessel coronary artery disease at time of index MI,
• Diagnosis of peripheral artery disease (extracoronary vascular disease, e.g. lower extremity artery disease or carotid artery disease).
Exclusion Criteria:
1. Diagnosis of chronic Heart Failure (HF) prior to index MI. 2. Systolic blood pressure < 90 mmHg at randomisation. 3. Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomisation. 4. Coronary Artery Bypass Grafting planned at time of randomisation. 5. Current diagnosis of Takotsubo cardiomyopathy. 6. Any current severe (stenotic or regurgitant) valvular heart disease. 7. eGFR < 20 ml/min/1.73m2 (using CKD-EPI formula based on most recent creatinine from local lab during index hospitalisation) or on dialysis. 8. Type I diabetes mellitus. Further exclusion criteria apply.
Drug: Empagliflozin, Drug: Placebo
Myocardial Infarction
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