RECRUITINGOBSERVATIONAL

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

Women's Ischemia Syndrome Evaluation (WISE) Mechanisms of Coronary Microvascular Dysfunction Leading to Pre-Heart Failure With Preserved Ejection Fraction (HFpEF)

About This Trial

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, participants will then have the option of participating in ongoing annual check-in calls. Participants will be asked to undergo a physical exam and provide a completed medical history; complete a Cardiovascular (or Cardiac) Magnetic Resonance Imaging (CMRI) with contrast agent; complete questionnaires to describe heart symptoms and overall quality of life status; undergo blood draws to provide blood samples for research testing, and allow the study team to have access to medical records.

Who May Be Eligible (Plain English)

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 willing to sign a consent form 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Locations (2)

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of Florida

Gainesville, Florida, United States