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Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF

Recruitingn/aAges 18 Years - anyAllCedars-Sinai Medical Center
NCT03876223 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to examine small vessel disease (a condition in which the small arteries in the heart become narrowed). The investigators want to know how the small vessel disease contributes to pre-HFpEF (a condition with inadequate heart muscle function in the setting of preserved muscle pumping) and to better identify potential treatment for prevention of HFpEF. The main procedures of this study include up to 2 clinic visits (initial visit and a second clinical visit only if participants are unable to complete all research procedures at the initial visit); a 6-week phone interview visit, 4 quarterly follow-up phone interview visits in year 1; year 1 follow up cardiac MRI based on availability and ongoing annual follow-up phone interview visits to track progress. If participants choose to take part in this study, participants direct participation will end after 1 year, par

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📋 Eligibility rules (as published)
Inclusion: 1. 180 symptomatic men and women undergoing invasive coronary angiography for suspected ischemia with no obstructive CAD, defined as ≥50% luminal diameter stenosis in ≥1 epicardial coronary artery. 2. Preserved left ventricular ejection fraction (EF) ≥45% 3. Be \> 18 years old 4. Be able to meet the requirement for a cardiac MRI, which means no metal devices in your chest, no claustrophobia and no angioedema 5. Be competent to give informed consent Exclusion: 1. Subjects with severe or chronic kidney disease (CKD) with GFR\<405 or acute kidney injury 2. Subjects with allergy to animal dander will be excluded since imaging will be done in BIRI (BIRI scanners are also used to image animals). 3. Subjects who have had four or more prior previous gadolinium contrast scans 4. Allergy/ hypersensitivity to adenosine, gadolinium, aminophylline or regadenoson 5. Second- or third-degree A-V block 6. Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) 7. Subjects with mild to severe asthma
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What it tests

  • Not listed
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Where

2 sites
Cedars-Sinai Medical Center
Los Angeles, United States
University of Florida
Gainesville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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