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52 Study Matches

Contrast Ultrasound for Pediatric Trauma - Comparative Evaluation (CAPTURE Study)

This multicenter study aims to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. Up to 130 subjects will complete the study across approximately 5-10 sites in the US, with up to 30 patients in the training phase (3 per site) and 100 patients in the treatment phase of the study. All subjects will have had a CT scan as part of standard of care, confirming at least one solid organ abdominal injury. The study procedure will occur within 48 hours from time of injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The CT and ultrasound scans will be read locally and will undergo central review.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Michael.Fulkerson@UTSouthwestern.edu
Jeannie Kwon
83212
All
8 Years to 18 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04718441
STU-2020-1359
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Inclusion Criteria:
1. Hemodynamically stable, as determined by the trauma team 2. Age 8 through 18 years (inclusive) 3. Interpretable CT of the abdomen and pelvis that demonstrates at least one solid organ injury among the liver, spleen, pancreas, and kidneys 4. Plan for observation or admission to the hospital 5. Candidate for abdominal ultrasound based on body habitus, as determined by the investigator 6. Glasgow Coma Score of 15 7. Able to complete the study procedures within 48 hours of injury
Exclusion Criteria:
1. Known cardiac abnormality 2. Pulmonary Hypertension 3. Known sensitivity to any Lumason components
•including sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid 4. Unable to be rolled onto side to allow lateral ultrasound windows if necessary 5. Unable to assent or consent 6. Pregnant 7. Lactating 8. CT images not available for transmission to central image repository
Drug: Lumason
Cardiovascular, Gall Bladder, Kidney, Liver, Pancreas, Soft Tissue, Abdominal Injury
Solid Organ Injury
Children’s Health
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A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT) (SUMMIT)

The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Ayushi.Vashisht@UTSouthwestern.edu
Ambarish Pandey
125045
All
40 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04847557
STU-2022-1074
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Inclusion Criteria:

• Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%
• Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) > 200 pg/ml for participants without atrial fibrillation (AF), or >600 picogram/milliliter (pg/ml) for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure
• Estimated glomerular filtration rate (eGFR) <70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening,
• Stable dose of heart failure medications within 4 weeks of screening
• Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²)
• 6MWD 100-425m
• KCCQ CSS ≤80
Exclusion Criteria:

• Have had a major cardiovascular event within the last 90 days of screening
• Have had acute decompensated heart failure within 4 weeks of screening
• Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions
• Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular hear disease
• HbA1c ≥9.5% or uncontrolled diabetes
• History of proliferative diabetic retinopathy or diabetic maculopathy
• Have a history of pancreatitis
• eGFR <15 mL/min/1.73 m² or requiring dialysis at screening
Drug: Tirzepatide, Other: Placebo
Heart Failure With Preserved Ejection Fraction, Obesity
Heart Failure with Preserved Ejection Fraction (HFpEF)
UT Southwestern
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AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (ARCADIA)

Objectives - Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. - Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Jessica.Clark@UTSouthwestern.edu
Ty Shang
137563
All
45 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03192215
STU 112017-065
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Inclusion Criteria:

• Age ≥ 45 years.
• Clinical diagnosis of ischemic stroke + brain imaging to rule out hemorrhagic stroke.
• Modified Rankin Scale (MRS) score ≤ 4.
• Ability to be randomized within 3 to 180 days after stroke onset.
• ESUS, defined as all of the following:
• Stroke detected by CT or MRI that is not lacunar. Lacunar is defined as a subcortical (this includes pons and midbrain) infarct in the distribution of the small, penetrating cerebral arteries whose largest dimension is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images/<1.5 cm on T2 weighted MR images. The following are not considered lacunes: multiple simultaneous small deep infarcts, lateral medullary infarcts, and cerebellar infarcts. Patients with a clinical lacunar stroke syndrome and no infarct on imaging are excluded.
• Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia. Patients must undergo vascular imaging of the extracranial and intracranial vessels using either catheter angiography, CT angiogram (CTA), MR angiogram (MRA), or ultrasound, as considered appropriate by the treating physician and local principal investigator.
• No major-risk cardioembolic source of embolism, including intracardiac thrombus, mechanical prosthetic cardiac valve, atrial myxoma or other cardiac tumors, moderate or severe mitral stenosis, myocardial infarction within the last 4 weeks, left ventricular ejection fraction <30 percent, valvular vegetations, or infective endocarditis). Patent foramen ovale is not an exclusion. All patients must undergo electrocardiogram, transthoracic or transesophageal echocardiography (TTE or TEE) and at least 24 hours of cardiac rhythm monitoring (Holter monitor or telemetry or equivalent). Additional cardiac imaging, such as cardiac MRI, or cardiac CT will be performed at the discretion of the local treating physician and principal investigator. Additional cardiac rhythm monitoring, such as monitored cardiac outpatient telemetry (MCOT) or an implanted cardiac monitor, will be at the discretion of the treating physician and local principal investigator.
• No other specific cause of stroke identified, such as arteritis, dissection, migraine, vasospasm, drug abuse, or hypercoagulability. Special testing, such as toxicological screens, serological testing for syphilis, and tests for hypercoagulability, will be performed at the discretion of the treating physician and local principal investigator.
Exclusion Criteria:

• History of atrial fibrillation (AF), AF on 12-lead ECG, or any AF of any duration during heart-rhythm monitoring prior to randomization.
• Clear indication for treatment-dose anticoagulant therapy, such as venous thromboembolism or a mechanical heart valve.
• Need for antiplatelet agent, such as aspirin or clopidogrel
• History of spontaneous intracranial hemorrhage.
• Chronic kidney disease with serum creatinine ≥2.5 mg/dL.For Canadian sites only, estimated creatinine clearance (eCrCl) <15 mL/min is also an exclusion criterion.
• Active hepatitis or hepatic insufficiency with Child-Pugh score B or C.
• Clinically significant bleeding diathesis.
• Unresolved anemia (hemoglobin <9 g/dL) or thrombocytopenia (<100 x 10E9/L).
• Clinically significant gastrointestinal bleeding within the past year (e.g., not due to external hemorrhoids).
• At risk for pregnancy: premenopausal or postmenopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control, which includes an oral contraceptive, two methods of barrier birth control such as condom with or without spermicidal lubricant + diaphragm, or abstinence.
• Known allergy or intolerance to aspirin or apixaban.
• Concomitant participation in another clinical trial involving a drug or acute stroke intervention.
• Considered by the investigator to have a condition that precludes follow-up or safe participation in the trial.
• Inability of either participant or surrogate to provide written, informed consent for trial participation.
Drug: Apixaban, Drug: Aspirin
Stroke, Brain and Nervous System
Atrial Cardiopathy, Cryptogenic stroke, Ischemic stroke, Apixaban, Aspirin
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Mechanisms of Exercise Intolerance in Heart Failure With Preserved Ejection Fraction

The global objective of this study is to determine the mechanisms of exercise intolerance and dyspnea on exertion (DOE) in patients with HFpEF and based on this pathophysiology, test whether specific exercise training programs (whole body vs single leg) will result in improved exercise tolerance.
Call 214-648-5005
studyfinder@utsouthwestern.edu, sheryllivingston@texashealth.org
Benjamin Levine
14262
All
60 Years to 90 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04068844
STU-2019-0617
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Inclusion Criteria:

• signs and symptoms of heart failure
• an ejection fraction > 0.50
• objective evidence of diastolic dysfunction
Exclusion Criteria:

• age < 60 years
• BMI > 50 kg/m2
• PDE5 inhibitor use
• Severe valvular disease
• Severe COPD
• CKD 4 or higher
• Contra-indication to MRI.
Behavioral: Exercise training
Heart Failure, Diastolic
Exercise, Hemodynamics,, Heart failure
UT Southwestern
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CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM receiving available standard of care (SoC). For more information, please visit https://www.cardio-ttransform.com.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Therese.Vallina@UTSouthwestern.edu
Justin Grodin
74652
All
18 Years to 90 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04136171
STU-2019-1609
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Inclusion Criteria:

• Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal or abstinent. If engaged in sexual relations of child-bearing potential, agree to use 1 highly effective contraceptive method
• Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the participant or the participant's non-pregnant female partner must be using a highly effective contraceptive method
• Amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or equivalent) staining OR technetium scintigraphy (99mTc -3,3-diphosphono-1,2- propanodicarboxylic acid [DPD-Tc], 99m Tc-pyrophosphate [PYP-Tc], or 99m Tc-hydroxymethylene-diphosphonate [HMDP-Tc]) with Grade 2 or 3 cardiac uptake in the absence of abnormal light chains ratio, centrally confirmed
• End-diastolic interventricular septum thickness of > 12 millimeters (mm) on Screening echocardiogram
• New York Heart Association (NYHA) class I-III
Exclusion Criteria:

• Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening
• Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease
• Monoclonal gammopathy of undetermined significance (MGUS) and/or alterations in immunoglobulin free light chain (FLC) ratio unless fat, bone marrow, or heart biopsy confirming the absence of light chain and the presence of TTR protein by mass spectrometry or immunoelectron microscopy. For participants with chronic kidney disease (CKD) and without presence of monoclonal protein in blood and urine, the acceptable FLC ratio is 0.26-2.25. Results different from that may be discussed with local hematologist, Investigator and Medical Monitor if the risks associated with the biopsy outweigh the benefits
• Prior liver or heart transplant, and/or Left Ventricular Assist Device (LVAD) or anticipated liver transplant or LVAD within 1 year after randomization
• Current or previous treatment with Tegsedi™ (inotersen) or Onpattro™ (patisiran) or other oligonucleotide or ribonucleic acid (RNA) therapeutic (including small interfering ribonucleic acid [siRNA]; does not apply to COVID-19 mitochondrial [mRNA] vaccinations)
• Current treatment with diflunisal, doxycycline, with or without ursodeoxycholic acid, and/or non-dihydropyridine calcium-channel blocker (e.g., verapamil, diltiazem). Participants receiving any of these agents must respect a wash-out period of 14 days before randomization.
Drug: Eplontersen, Drug: Placebo
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
TTR, Amyloidosis, Cardiomyopathy
UT Southwestern
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Polypill Strategy for Heart Failure With Reduced Ejection Fraction

Heart failure with a reduced ejection fraction (HFrEF) represents a significant public health burden in the United States, with a growing prevalence particularly among African Americans and Hispanic Americans and individuals of low socioeconomic status (SES). Although effective therapies exist, gaps in their uptake contribute substantially to the excess burden of heart failure. The "polypill" is an inexpensive once daily pill containing three agents proven to improve morbidity and mortality in heart failure and represents potential strategy for increasing the utilization of proven HF therapies. The proposed study is a pragmatic, single-center, randomized trial to test the feasibility and effectiveness of a polypill-based strategy for the treatment of HFrEF in a low-income, racially diverse population.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Sujitha.Vasireddy@UTSouthwestern.edu
Ambarish Pandey
125045
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04633005
STU-2020-1340
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Inclusion Criteria:

• Adults age > = 18 years
• HF with left ventricular ejection fraction <= 40% within 3 months of screening who are not on optimal guideline directed medical therapy
• New York Heart Association class II, III, or IV symptoms
Exclusion Criteria:

• Age < 18
• Systolic blood pressure < 120 mm Hg at enrollment
• Estimated glomerular filtration rate < 30 mL/min/1.73 m2 as measured by the simplified
• MDRD formula
• Serum potassium > 5.0 mEq/L
• Current need for inotropes
• Cardiac index < 2.2 L/min/m2
• History of revascularization within 30 days or plan for revascularization
• History of type 1 diabetes mellitus
• History of allergic reaction or contraindication to a beta-blocker (BB), mineralocorticoid receptor antagonist (MRA), or sodium glucose cotransporter 2 inhibitor (SGLT2i)
• Contraindication to receive any of the components of the polypill
• Pregnancy
• < 12 month expected survival
• Inability to provide written informed consent
• Persistent or permanent atrial fibrillation who may not have optimal MRI imaging
• Extreme obesity (BMI > 45 kg/m2)
• ICD/PAcemaker devices that are incompatible with MRI
Drug: Polypill, Drug: Control Rx
Heart Failure, Heart
UT Southwestern; Parkland Health & Hospital System
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A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease (COORDINATE)

COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with type 2 diabetes mellitus and cardiovascular disease.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Vukile.Mlambo@utsouthwestern.edu
Ambarish Pandey
125045
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03936660
STU-2020-0323
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Inclusion Criteria:

• Age ≥ 18 years old
• Diagnosis of Type 2 diabetes mellitus (T2DM)
• History of at least one of the following conditions: 1. Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA) 2. Stroke and/or carotid artery stenosis (≥50%) 3. Peripheral Arterial disease (defined as claudication with ABI<0.9, prior peripheral revascularization, and/or amputation due to circulatory insufficiency)
• Ability to communicate with site staff and understand and provide written informed consent and proof of Health Insurance Portability and Accountability Act (HIPAA) authorization
Exclusion Criteria:

• Determined to be highly unlikely to survive and/or to continue follow-up in that clinic for at least 1 year, as identified by site investigator
• GFR<30 mL/min/1.73m2
• Already on all guideline-recommended therapies for T2DM and CVD
• Absolute contraindication to any of the guideline recommended therapies for T2DM and CVD
Other: Intense Education Intervention
Diabetes Mellitus, Type 2, Cardiovascular Diseases
COORDINATE-DIABETES, COORDINATE, T2DM, Diabetes Mellitus, Type 2, Cardiovascular Disease, Prevention
UT Southwestern; Parkland Health & Hospital System
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Cancer and Blood Pressure Management, CARISMA Study

This phase II trial studies how well intensive blood pressure management works in decreasing systolic blood pressure in patients with kidney or thyroid cancer that has spread to other places in the body (metastatic) who are starting anti-angiogenic tyrosine kinase inhibitor cancer therapy. This study is being done to find out if a systolic blood pressure to a target of less than 120 mmHg (intensive systolic blood pressure management) can be achieved, well tolerated, and beneficial as compared to the usual approach to a target of less than 140 mmHg while taking an anti-angiogenic tyrosine kinase inhibitor. This study may help doctors understand the best way to control blood pressure in kidney or thyroid cancer patients taking anti-angiogenic tyrosine kinase inhibitor.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Vlad Zaha
163027
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04467021
STU-2021-0661
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Inclusion Criteria:

• English speaking
• Patient must have histologically or cytologically-proven advanced metastatic renal cell cancer (mRCC) or medullary thyroid cancer initially treated with anti-angiogenic tyrosine kinase inhibitors (AA-TKIs) including: sunitinib, sorafenib, pazopanib, cabozantinib, lenvatinib, vandetanib, or axitinib)
• NOTE: If patient has a severe sulfa allergy (e.g. Stevens Johnson reaction), then alternative non-sulfa medications can be considered in consultation with the C-BAC. Patient with a noted severe allergic reactions to medications listed in the algorithms is not necessarily excluded from this trial, as alternative medications could be considered in consultation with the C-BAC. Moreover, the patient treated with pre-existing medications that may interact with proposed BP medications is not necessarily excluded, as alternative medications exist. The clinical significance of any potential drug interactions can also be addressed with the C-BAC.
• Prior exposure to another AA-TKI is permissible. Concurrent or prior treatment with immunotherapy is also permissible
• Patient must have either clinical cardiovascular (CV) disease or evidence of increased CV risk as defined by one or more of the following:
• Clinical CV disease (history of myocardial infarction [MI] acute coronary syndrome, coronary revascularization, carotid endarterectomy or stenting greater than 3 months prior to registration, peripheral artery disease, cerebrovascular accident greater than 3 months prior to registration, abdominal aortic aneurysm or heart failure [HF])
• An American College of Cardiology/American Heart Association (ACC/AHA) CV risk score of at least 10%
• Chronic kidney disease (defined as an estimated glomerular filtration rate [eGFR] between 30 and 60 ml/min per 1.73 m^2). Dialysis patients and patients with an eGFR < 30 ml/min/1.73m^2 will be excluded. eGFR will be calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation
• Patient must have systolic blood pressure (SBP) >= 130 mmHg on two or more occasions according to any in-clinic visit in the 12 weeks prior to or during their initial 4 weeks of treatment with an AA-TKI. Patient who have a prior diagnosis of hypertension or on pre-existing anti-hypertensive medications are eligible for enrollment. However, patient must not be on more than 3 baseline blood pressure medications at time of entry
• NOTE: If a patient has a single elevated SBP >= 130mmHg but not on repeat assessment, an additional SBP assessment should be performed to confirm ineligibility
• Patient must agree to comply with performing home blood pressure monitoring using an Omron7250 oscillometric monitor at home, or equivalent models
• Women of childbearing potential and sexually active males must be strongly advised to use accepted and effective methods of contraception or to abstain from sexual intercourse for the duration of their participation in the study
• Patient must have internet access through a computer, tablet, or smart phone to use EASEE-PRO and home BP monitoring. A valid phone number to receive text messages and email address are also necessary
• Leukocytes >= 3,000/mcL (obtained within 14 days prior to registration)
• Absolute neutrophil count >= 1,500/mcL (obtained within 14 days prior to registration)
• Platelets >= 100,000/mcL (obtained within 14 days prior to registration)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to registration)
• Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• Patient with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• Patient with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
• Patient with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
• Patient with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria:

• Patient must not have end-stage renal failure on dialysis, history of repeated hyperkalemia with a potassium > 5.5 mEq/l, or have a kidney transplant, or an eGFR < 30 ml/min/1.73 m^2
• Patient must not have coronary artery bypass grafting, MI acute coronary syndrome severe/unstable angina, stroke, transient ischemic attack, clinically significant bleeding requiring hospitalization or pulmonary embolism within 3 months prior to registration
• Patient must not have brain surgery or radiotherapy within 2 weeks prior to registration
• Patient must not have uncontrolled blood pressure defined by SBP > 160 mmHg on three or more antihypertensives prior to TKI initiation
• Patient with an arm circumference too large (> 50 cm) or small (< 17 cm) to allow accurate BP measurement with available devices will not be eligible
• Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with some anti-hypertensives, including angiotensin receptor blockers. All females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has achieved menarche at some point, has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Other: Best Practice, Other: Blood Pressure Measurement, Other: Clinical Management, Other: Quality-of-Life Assessment, Other: Questionnaire Administration
Metastatic Renal Cell Carcinoma, Chronic Kidney Disease, Stage IV Renal Cell Cancer AJCC v8, Kidney, Cardiovascular Disorder, Metastatic Thyroid Gland Medullary Carcinoma, Stage IV Thyroid Gland Medullary Carcinoma AJCC v8, Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8, Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8, Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8
UT Southwestern
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COMPASSION S3 Post-Approval Study

This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.
Call 214-648-5005
studyfinder@utsouthwestern.edu, kirstie.ledoux@childrens.com
Thomas Zellers
18301
All
Not specified
This study is NOT accepting healthy volunteers
NCT04860765
STU-2021-0535
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Inclusion Criteria:
1. Dysfunctional RVOT conduit or previously implanted surgical valve 2. RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg
Exclusion Criteria:
1. Inability to tolerate an anticoagulation/antiplatelet regimen 2. Active bacterial endocarditis or other active infections
Device: SAPIEN 3 THV
Pulmonary Valve Insufficiency, Cardiovascular, Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Degeneration, Pulmonary Valve, Obstruction
Transcatheter pulmonary valve replacement, Transcatheter pulmonary valve implantation, SAPIEN 3
Children’s Health
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Impact of Intensive Treatment of SBP on Brain Perfusion, Amyloid, and Tau (IPAT Study) (IPAT)

The purpose of this study is to determine if intensive lowering of systolic blood pressure (SBP), using FDA approved medications (antihypertensive), reduces Alzheimer's Disease pathology (i.e., excessive brain amyloid and tau protein deposition) in older adults at high risk for memory decline or dementia.
Call 214-648-5005
studyfinder@utsouthwestern.edu, TristynHall@texashealth.org
Rong Zhang
18315
All
60 Years to 80 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT05331144
STU-2021-1210
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Inclusion Criteria:

• Age 60-80, all races/ethnicities, and both sexes are eligible;
• a) A positive family history of dementia defined as having at least one first-degree relative with a history of AD or other type of dementia or
• b) having subjective memory complaints defined as a positive answer to BOTH of the following questions: 1. "Are you worried about your memory or thinking abilities? a) Not at all, b) A little bit, c) A lot"; B and C
•includes 2. "Do you feel you have difficulty with your memory or thinking that is worse than in the past?" b) Yes or No; Yes
•includes
• Mini-Mental State Exam (MMSE) ≥ 26 to exclude gross dementia; based on clinical judgment, may be rescreened in ≥ 7 days;
• Individuals with SBP ≥ 130 and SBP ≤ 180; Those on antihypertensives are eligible. If an individual, not treated for HTN, has a SBP ≥ 125 mmHg, consider rescreening after 24 hours;
• Willingness to be randomized into the treatment groups and ability to return to clinic for follow-up visits over 24 months;
• Fluency in English or Spanish or both, adequate visual and auditory acuity to allow neuropsychological testing;
• Participants must have a regular healthcare provider.
Exclusion Criteria:

• Clinically documented history of stroke, focal neurological signs or other major cerebrovascular diseases based on clinical judgment or MRI/CT scans such as evidence of infection, infarction, or other brain lesions;
• Diagnosis of AD or other type of dementia, or significant neurologic diseases such as Parkinson's disease, seizure disorder, multiple sclerosis, history of severe head trauma or normal pressure hydrocephalus;
• Evidence of severe major depression (GDS ≥ 12, may be rescreened after 12 weeks or longer if evidence of reactive depression or temporary mood disturbances) or clinically significant psychopathology, (e.g., psychosis and schizophrenia); if hospitalized in past year, can be rescreened in 6 months; or presence of a major psychiatric disorder that in the investigator's opinion, could interfere with adherence to research assessments or procedures.
• Unstable heart disease based on clinical judgment (e.g., heart attack/cardiac arrest, cardiac bypass procedures within previous 6 months and congestive heart failure), or other severe medical conditions;
• History of atrial fibrillation and evidence on ECG with any of the following: active symptoms of persistent palpitation, dizziness, history of syncope, chest pain, dyspnea, orthopnea, shortness of breath at rest, or paroxysmal nocturnal dyspnea within the past 6 months; resting heart rate of < 30 or > 110 bpm; taking class I or III antiarrhythmic drugs including flecainide, propafenone, dronedarone, sotalol, dofetilide, and amiodarone; or clinical concerns for safely participating in lowering blood pressure.
• Systolic BP equal or greater than 180 mmHg and/or diastolic BP equal or greater than 110 mmHg, may be rescreened in 1 week.
• Orthostatic hypotension, defined as the third standing SBP < 100mmHg, may be rescreened after 2 weeks;
• History of significant autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis or polymyalgia rheumatica;
• Significant history of alcoholism or drug abuse within the last five years;
• Uncontrolled diabetes mellitus, defined as hemoglobin A1C > 6.5%, or requiring insulin treatment;
• Clinically diagnosed and untreated sleep apnea;
• Regularly smoking cigarettes within the past year;
• Pacemaker or other medical device of metal that precludes performing MRI;
• Women with a potential for pregnancy, lactation/childbearing (2 year post-menopausal or surgically sterile to be considered not childbearing potential);
• Participant enrolled in another investigational drug or device study, either currently or within the past 2 months;
• Severe obesity with BMI > 40 ; clinical judgment should be applied in all cases to assess patient safety and anticipated compliance;
• Allergy to angiotensin receptor blockers (ARBs), i.e., drugs that have a suffix "-sartan"; allergy to amlodipine;
• Abnormal screening laboratory tests (e.g., liver ALT and AST > 3 x ULN, GFR < 30 or Hct < 28%); may be rescreened after 2 weeks or longer;
• A medical condition likely to limit survival to less than 3 years;
• Participant has any condition(s) judged by the study investigator to be medically inappropriate, risky or likely to cause poor study compliance. For example: 1. Plans to move outside the clinic catchment area in the next 2 years; 2. Significant concerns about participation in the study from spouse, significant other, or family members; 3. Lack of support from primary health care provider; 4. Residence too far from the study clinic site such that transportation is a barrier including persons who require transportation assistance provided by the study clinic funds for screening or randomization visits; 5. Residence in a nursing home; persons residing in an assisted living or retirement community are eligible if they meet the other criteria; 6. Other medical, psychiatric, or behavioral factors that, in the judgment of the site PI or clinician, may interfere with study participation or the ability to follow the study Protocol. 7. Couples or significant partners who live together cannot be enrolled or participate simultaneously in the study.
Drug: Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine), Other: PCP
Hypertension, Cognitively Normal Older Adults, Subjective Cognitive Decline, Brain and Nervous System, Family History of Dementia
Dementia, Alzheimer's Disease, Cognitive Function, Blood Pressure, Amyloid, Tau
UT Southwestern
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Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes (STEP HFpEF DM)

This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight. This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms. Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm. During the study participants will have talks with the study staff about healthy lifestyle and physical activity. The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor. - At 6 of the visits participants will have blood samples taken. - At 5 of the visits participants will be asked to fill in a questionnaire - At 4 of the visits participants will have to do a 6-minute walking test - At 3 of the visits participants will have a test to check the heart. - participants will have their eyes checked before or at the start of the study and at the end of the study Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Ayushi.Vashisht@UTSouthwestern.edu
Ambarish Pandey
125045
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04916470
STU-2021-1149
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Inclusion Criteria:

• Male or female, age above or equal to 18 years at the time of signing informed consent.
• Body mass index (BMI) greater than or equal to 30.0 kg/m^2
• New York Heart Association (NYHA) Class II-IV
• Left ventricular ejection fraction (LVEF) greater than or equal to 45% at screening
• Diagnosed with T2D greater than or equal to 90 days prior to the day of screening
• HbA1c of below or equal to 10.0% as measured at the screening visit
Exclusion Criteria:

• A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Drug: Semaglutide, Drug: Placebo (Semaglutide)
Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2
UT Southwestern
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Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP) (ICECAP)

This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.
Call 214-648-5005
studyfinder@utsouthwestern.edu, kirstie.ledoux@childrens.com
Joshua Wolovits
49698
All
2 Days to 17 Years old
N/A
This study is NOT accepting healthy volunteers
NCT05376267
STU-2022-0800
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Inclusion criteria:
• Age 2 days to < 18 years with corrected gestational age of at least 38 weeks
• Chest compressions for at least 2 minutes
• Coma or encephalopathy after resuscitation from Out-of-Hospital Cardiac Arrest (OHCA)
• Requires continuous mechanical ventilation through endotracheal tube or tracheostomy
• Definitive temperature control device initiated
• Randomization within 6 hours of Return of Spontaneous Circulation (ROSC)
• Informed consent from Legally Authorized Representative (LAR) including intent to maintain life support for 120 hours Exclusion criteria:
• Glasgow Coma Motor Score (GCMS) = 6
• LAR does not speak English or Spanish
• Duration of Cardiopulmonary Resuscitation (CPR) > 60 minutes
• Severe hemodynamic instability with continuous infusion of epinephrine or norepinephrine of 2 micrograms per kilogram per minute (μg/kg/minute) or initiation of Extracorporeal membrane oxygenation (ECMO)
• Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or progressive degenerative encephalopathy
• Pre-existing terminal illness, unlikely to survive to one year
• Cardiac arrest associated with brain, thoracic, or abdominal trauma
• Active and refractory severe bleeding prior to randomization
• Extensive burns or skin lesions incompatible with surface cooling
• Planned early withdrawal of life support before 120 hours
• Sickle cell anemia
• Pre-existing cryoglobulinemia
• Non-fatal drowning in ice covered water
• Central nervous system tumor with ongoing chemotherapy
• Previous enrollment in P-ICECAP trial
• Prisoner
• Chronic hypothermia
• New post-cardiac arrest diabetes insipidus
• Pregnancy
Device: Therapeutic Hypothermia
Hypoxia-Ischemia, Brain, Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced
Bayesian Adaptive Clinical Trial, Hypothermia, therapeutic, Coma, Pediatric
Children’s Health
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Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction (MUSIC-HFrEF1)

It is believed that targeted SERCA2a enzyme replacement in HFrEF patients will correct defective intracellular Ca2+ hemostasis, resulting in improved cardiac contractile function and energetics which will, in turn, translate to improved clinical outcomes. Additionally, it is hypothesized that correcting SERCA2a dysfunction will also improve coronary blood flow through correction of the impaired endothelium-dependent nitric oxide-mediated vasodilatation observed in heart failure.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Therese.Vallina@UTSouthwestern.edu
Justin Grodin
74652
All
18 Years to 80 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04703842
STU-2022-0321
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Main
Inclusion Criteria:

• Chronic ischemic or non-ischemic cardiomyopathy
• NYHA class III/IV
• LVEF ≤35%
• Maximal, optimized heart failure therapy; ICD Main
Exclusion Criteria:

• Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm
• Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), mechanical circulatory support device (MCSD) or cardiac shunt
• Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, conventional revascularization procedure or valvular repair in the 6 months following treatment
• Likely need for an immediate heart transplant or MCSD implant due to hemodynamic instability
• Inadequate hepatic and renal function
• Diagnosis of, or treatment for, any cancer within the last 5 years except for basal cell carcinoma or carcinomas in situ where surgical excision was considered curative
Biological: SRD-001, Drug: Placebo
Congestive Heart Failure, Heart Failure, Heart Failure, Systolic, Heart
UT Southwestern
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Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE) (INSPIRE)

The Innovative Support for Patients with SARS COV-2 Infections Registry (INSPIRE) study is a CDC-funded COVID-19 project to understand the long-term health outcomes in recently tested adults, both negative and positive, who have suspected COVID symptoms at the time of their test. Participants will complete short online surveys every 3 months for 18 months, share information about their health using a secure web-based platform, and are compensated for their time.
Call 214-648-5005
studyfinder@utsouthwestern.edu, DAVID.GALLEGOS@UTSouthwestern.edu
Ahamed Idris
58880
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT04610515
STU-2020-1352
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INCLUSION CRITERIA 1. Fluent in English or Spanish; 2. Age 18 and over; 3. Self-reported symptoms suggestive of acute SARSCOV2 infection; 4. Under investigation for SARSCOV2 (defined as a patient who has received any screening or diagnostic test used to detect the presence of COVID19 including any FDA approved or authorized molecular or antigen-based assay) within the last 42 days. EXCLUSION CRITERIA 1. Unable to provide informed consent; 2. Study team unable to confirm result of diagnostic test for SARSCOV2; 3. Does not have access to a hand-held device or computer that would allow for digital participation in the study; 4. Individuals who are prisoners while participating in the study.
Cardiovascular Diseases, Covid19, ME/CFS, SARS COV2, Novel Coronavirus Infection, Neurocognitive Disorders
UT Southwestern
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A Study of ISIS 678354 Administered to Participants With Severe Hypertriglyceridemia

The purpose of the study is to evaluate the efficacy of ISIS 678354 as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Lakeisha.Cade@UTSouthwestern.edu
Zahid Ahmad
69829
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05079919
STU-2021-0926
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Key
Inclusion Criteria:

• Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
• Patients should be on standard of care lipid-lowering medications per local guidelines unless intolerant. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to Screening to minimize changes in these medications during the study. Key
Exclusion Criteria:

• Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
• Platelet count < 100K/cubic millimeters at Screening or Qualification
• Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
• Total bilirubin > upper limit of normal unless due to Gilbert's syndrome
• Estimated GFR < 40 mL/min/1.73 m^2
Drug: ISIS 678354, Drug: Placebo
Severe Hypertriglyceridemia
ISIS 678354, Fasting Triglycerides, Apolipoprotein C-III, Very Low-Density Lipoprotein Cholesterol, High-Density Lipoprotein-Cholesterol, Non-High-Density Lipoprotein-Cholesterol
UT Southwestern
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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
Call 214-648-5005
studyfinder@utsouthwestern.edu, Bonnie.Orth@UTSouthwestern.edu
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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Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection Fraction (REHAB-HFpEF)

studyfinder@utsouthwestern.edu
All
60 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05525663
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Inclusion Criteria:
1. Age >=60 years old 2. Ejection Fraction >=45% 3. In the hospital setting >24 hours for the management of acute decompensated heart failure (ADHF), or diagnosed with ADHF after being hospitalized for another reason. ADHF will be confirmed by the site physician, and will be defined according to the Food and Drug Administration (FDA) definition of hospitalized heart failure as a combination of symptoms, signs, and HF-specific medical treatments, and requires that all 4 of the following are met:
• At least 1 symptom of HF which has worsened from baseline: a. dyspnea at rest or with exertion; b. exertional fatigue; c. orthopnea; d. paroxysmal nocturnal dyspnea (PND)
• At least 2 of the following signs of HF: a. Pulmonary congestion or edema on physical exam (rales or crackles) or by chest X-ray; b. Elevated jugular venous pressure or central venous pressure >=10 mm Hg; c. peripheral edema; d. wedge or left ventricular end diastolic pressure >=15 mmHg; e. rapid weight gain (>=5 lbs.); f. Increased b-type natriuretic peptide (BNP) (>=100 pg/ml) or N-terminal prohormone BNP (>=220pg/ml)
• Change in medical treatment specifically targeting HF, defined as change in dose or initiation of or augmentation of at least 1 of the following therapies: a. diuretics; b. vasodilators; c. other neurohormonal modulating agents, including angiotensinconverting enzyme inhibitors, angiotensin II receptor blockers (with or without neprilysin inhibitor), beta-blockers, aldosterone inhibitors, direct renin inhibitors, or sodium-glucose co-transporter-2 inhibitors
• The primary cause of symptoms and signs is judged by the investigator to be due to HF 4. Adequate clinical stability to allow participation in study assessments and the intervention Independent with basic activities of daily living, including the ability to ambulate independently (with or without the use of an assistive device) prior to admission 5. Able to walk 4 meters (with or without the use of an assistive device) at the time of enrollment
Exclusion Criteria:
1. Acute myocardial infarction within the past 3 months, or planned coronary artery intervention (percutaneous or surgical) within the next 6 months (Note: given that cardiac biomarkers such as troponin are frequently elevated in HF patients, the diagnosis of acute myocardial infarction should be based on clinical diagnosis, not biomarkers alone) 2. Severe aortic or mitral valve stenosis 3. Severe valvular heart disease with planned intervention within next 6 months 4. Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis) 5. Planned discharge other than to home or a facility where the participant will live independently 6. Terminal illness other than HF with life expectancy <1 year 7. Impairment from stroke or other medical disorders that preclude participation in the intervention 8. Known dementia by medical record documentation, OR patients with Montreal Cognitive Assessment (MoCA) <=18 AND without social support, OR MoCA <10 regardless of social support 9. Advanced chronic kidney disease defined as estimated glomerular filtration rate <20 mL/min/1.73 m2 or on chronic or intermittent dialysis or dialysis anticipated within the next 6 months 10. Already engaging in regular moderate to vigorous exercise conditioning defined as >30 minutes per day, >= twice per week consistently during the previous 6 weeks 11. Enrollment in a clinical trial not approved for co-enrollment 12. High risk for non-adherence as determined by screening evaluation 13. Inability or unwillingness to comply with the study requirements or give consent
Behavioral: Rehabilitation Intervention
Heart Failure With Preserved Ejection Fraction
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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).
Call 214-648-5005
studyfinder@utsouthwestern.edu, kirstie.ledoux@childrens.com
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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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.
Call 214-648-5005
studyfinder@utsouthwestern.edu, kendra.malone@childrens.com
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 2 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
UT Southwestern; Children’s Health; Parkland Health & Hospital System
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Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials (VERIFY)

VERIFY will validate biomarkers of upper extremity (UE) motor outcome in the acute ischemic stroke window for immediate use in clinical trials, and explore these biomarkers in acute intracerebral hemorrhage. VERIFY will create the first multicenter, large-scale, prospective dataset of clinical, transmagnetic stimulation (TMS), and MRI measures in the acute stroke time window.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Madeleine.Euckert@UTSouthwestern.edu
Nneka Ifejika
166870
All
18 Years and over
This study is also accepting healthy volunteers
NCT05338697
STU-2021-1134
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Inclusion Criteria:

• Age 18 years or older
• Unilateral stroke due to ischemia or intracerebral hemorrhage
• Motor deficits in the acutely affected UE, defined as a Shoulder Abduction and Finger Extension (SAFE) score ≤ 8 out of 10 points (i.e., excluding full or nearly full motor strength in both shoulder abduction and finger extension) within 48 to 96 hours of stroke onset (or time last known well).
• Provision of signed and dated informed consent form within 48 to 96 hours of stroke onset (or time last known well).
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Fluent in English or Spanish
Exclusion Criteria:

• UE injury or conditions on paretic side that limited use prior to the stroke.
• Legally blind.
• Dense sensory loss indicated by a score of 2 on NIHSS sensory item
• Unable to abduct the shoulder or extend the fingers of the non-paretic arm/hand/wrist on verbal command
• Isolated cerebellar stroke
• Bilateral hemisphere acute strokes
• Co-enrollment in a trial of an intervention targeting the incident stroke (acute treatment or rehabilitation/recovery intervention) after baseline assessments for VERIFY are initiated
• Known or expected inability to maintain follow-up with study procedures through 90 days
• Cognitive or communication impairment precluding informed consent by the participant.
• Major medical, neurological, or psychiatric condition that would substantially affect functional status
• Non-cerebrovascular diagnosis associated with unlikely survival at 90 days
• Pregnancy
• Contraindication to noncontrast MRI (i.e., certain metallic implants, metallic foreign bodies or severe claustrophobia)
• Contraindication to TMS (i.e., cardiac pacemaker or other electronic devices in the body at or above the level of the seventh cervical vertebra, such as cochlear implant, cortical stimulator, deep brain stimulator, vagus nerve stimulator, cervical spine epidural stimulator, or ventriculoperitoneal shunt; Skull defect related to current stroke; Seizure after onset of current stroke; Seizure within the last 12 months while taking anti-epileptic medications; Previous serious adverse reaction to TMS)
• Unable to perform behavioral assessments within 48-120 hours of symptom onset
• Unable to receive TMS or get MRI within 72-168 hours of symptom onset
• Anticipated inability to perform study procedures within 168 hours of symptom onset.
Diagnostic Test: Transcranial Magnetic Stimulation (TMS)
Stroke, Stroke, Acute, Stroke Hemorrhagic, Stroke, Ischemic
UT Southwestern
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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, Monserrat.Feria-Vargas@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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Subclinical Transthyretin Cardiac Amyloidosis in V122I TTR Carriers

Approximately 1.5 million of the 44 million Blacks in the United States are carriers of the valine-to-isoleucine substitution at position 122 (V122I) in the transthyretin (TTR) protein. Virtually exclusive to Blacks, this is the most common cause of hereditary cardiac amyloidosis (hATTR-CA) worldwide. hATTR-CA leads to worsening heart failure (HF) and premature death. Fortunately, new therapies that stabilize TTR improve morbidity and mortality in hATTR-CA, especially when prescribed early in the disease. However, hATTR-CA is often diagnosed at an advanced stage and conventional diagnostic tools lack diagnostic specificity to detect early disease. The overall objectives of this study are to determine the presence of subclinical hATTR-CA and to identify biomarkers that indicate amyloid progression in V122I TTR carriers. The central hypothesis of this proposal is that hATTR-CA has a long latency period that will be detected through subclinical amyloidosis imaging and biomarker phenotyping. The central hypothesis will be tested by pursuing 2 specific aims: Aim 1) determine the association of V122I TTR carrier status with CMRI evidence of amyloid infiltration; Sub-aim 1) determine the association of V122I TTR carrier status with cardiac reserve; Aim 2) determine the association between amyloid-specific biomarkers and V122I TTR carrier status; and Sub-aim 2) determine the association of amyloid-specific biomarkers with imaging-based parameters and evaluate their diagnostic utility for identifying subclinical hATTR-CA. In Aim 1, CMRI will be used to compare metrics associated with cardiac amyloid infiltration between a cohort of V122I TTR carriers without HF formed by cascade genetic testing and age-, sex-, and race-matched non-carrier controls. For Sub-Aim 1, a sub-sample of carriers and non-carrier controls enrolled in Aim 1 will undergo novel exercise CMRI to measure and compare cardiac systolic and diastolic reserve. Aim 2 involves measuring and comparing amyloid-specific biomarkers in V122I TTR carriers without HF with samples matched non-carriers (both from Aim 1) and individuals with symptomatic V122I hATTR-CA from our clinical sites. These biomarkers detect and quantify different processes of TTR amyloidogenesis and include circulating TTR, retinol binding protein 4, TTR kinetic stability, and misfolded TTR oligomers. Sub-aim 2 will establish the role of these biomarkers to detect imaging evidence of subclinical hATTR-CA disease.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Carolyn.Kelly@UTSouthwestern.edu
Justin Grodin
74652
All
30 Years to 80 Years old
This study is NOT accepting healthy volunteers
NCT05489549
STU-2022-0404
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(V122I TTR carriers (or matched non-carriers))
Inclusion Criteria:

• Men and women ages 30-80 who are V122I TTR carriers (or matched non-carriers) without history of HF (this will be assessed by study personnel) and defined as: a) No history of hospitalization within the previous 12 months for management of HF; b) Without an elevated B-type natriuretic peptide level ≥100 pg/mL or NT-proBNP ≥360 pg/mL within the previous 12 months; or c) No clinical diagnosis of HF from a treating clinician
• Signed informed consent
Exclusion Criteria:

• A self-reported history or clinical history of HF
• Other known causes of cardiomyopathy
• History of light-chain cardiac amyloidosis
• Prior type 1 myocardial infarction (non-ST segment elevation myocardial Infarction {NSTEMI} or ST-elevation myocardial infarction {STEMI})
• Cardiac transplantation
• Body weight >250 lbs
• Estimated glomerular filtration rate ≤30 mL/min/1.73 m2
• Inability to safely undergo CMRI (For participants with symptomatic V122I hATTR-CA, we will enroll probands with HF from Aim 1 or patients with symptomatic V122I hATTR-CA from the three study sites.)
Inclusion Criteria:

• Men and women ages 30-80 who have symptomatic V122I hATTR-CA as determined by a history of HF (this will be assessed by study personnel) and defined as: a) History of hospitalization within the previous 12 months for management of HF; b) An elevated B-type natriuretic peptide level ≥100 pg/mL or NT-proBNP ≥360 pg/mL within the previous 12 months; or c) A clinical diagnosis of HF from a treating clinician.
• Have an established diagnosis of hATTR-CA based on either a) Biopsy confirmed by Congo red (or equivalent) staining with tissue typing with immunohistochemistry or mass spectrometric analysis or immunoelectron microscopy, OR b) positive technetium-99m (99mTc)-pyrophosphate or -bisphosphonate scan, combined with accepted laboratory criteria without abnormal M-protein.
• TTR gene sequencing confirming the V122I variant
• Signed informed consent
Exclusion Criteria:

• Other known causes of cardiomyopathy
• History of light-chain cardiac amyloidosis
• Cardiac transplantation
• Liver transplantation
• Previous Treatment with a TTR stabilizer (tafamidis, acoramidis) or TTR silencer (inotersen, patisiran, eplontersen)
• Estimated glomerular filtration rate ≤30 mL/min/1.73 m2
Amyloidosis, Hereditary, Cardiovascular, Transthyretin-Related (ATTR) Familial Amyloid Cardiomyopathy, Amyloidosis Cardiac, Amyloidosis, Familial, Transthyretin Gene Mutation
Amyloidosis, Transthyretin Amyloidosis, V122I TTR, p.Val142Ile TTR, Cardiac magnetic resonance imaging
UT Southwestern
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