Examining small vessel disease in women with heart issues

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

This study is trying to see how small blood vessel problems in the heart affect women with heart issues who don't have blocked arteries, to help understand heart failure better.

Quick facts

• Study type: Observational
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cedars-Sinai Medical Center (other)
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT03876223 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the role of coronary microvascular dysfunction (CMD) in the development of heart failure with preserved ejection fraction (HFpEF) among symptomatic individuals without obstructive coronary artery disease. Participants will undergo invasive coronary angiography and various assessments, including provocative stress testing and cardiac MRI, to evaluate myocardial ischemia and left ventricular function. The study will involve up to two clinic visits, followed by phone interviews and annual check-ins to monitor participants' progress over one year.

Who should consider this trial

Good fit: Ideal candidates include symptomatic men and women over 18 years old with preserved left ventricular ejection fraction and no obstructive coronary artery disease.

Not a fit: Patients with severe chronic kidney disease, significant allergies to imaging agents, or certain heart conduction issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better prevention strategies for heart failure in patients with coronary microvascular dysfunction.

How similar studies have performed: Other studies have shown promising results in understanding coronary microvascular dysfunction, but this specific approach is relatively novel.

Eligibility criteria

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

Where this trial is running

Los Angeles, California and 1 other locations

• Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
• University of Florida — Gainesville, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: C. Noel Bairey Merz, MD, FACC — Cedars-Sinai Medical Center
• Study coordinator: Nicole Tovar

Conditions: Coronary Microvascular Dysfunction, Heart Failure With Preserved Ejection Fraction, Coronary Vascular Dysfunction, Coronary angiography, Magnetic resonance imaging