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

Launched by CEDARS-SINAI MEDICAL CENTER · Mar 13, 2019

Keywords

ClinConnect Summary

The Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF study is looking into a condition called coronary microvascular dysfunction, which affects the small blood vessels in the heart. Researchers want to understand how this condition contributes to heart failure with preserved ejection fraction (HFpEF), where the heart muscle can pump well, but isn't functioning properly. By studying this, they hope to find better ways to prevent HFpEF. If you choose to participate, you would have up to two clinic visits and a series of follow-up phone calls over the course of a year. You will undergo tests, including a special heart scan (MRI), answer questionnaires about your heart symptoms and quality of life, and provide blood samples for research.

To be eligible for the study, you should be a man or woman aged 18 or older who has symptoms of heart issues but does not have major blockages in the larger heart arteries. You should also have a preserved heart function and meet certain health criteria, such as not having severe kidney problems or specific allergies. Your participation will last for one year, with options for annual check-ins afterward. This trial is an important opportunity to contribute to research that could improve care for individuals with similar heart conditions.

Gender

ALL

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