RecruitingNCT03876223

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)


Sponsor

Cedars-Sinai Medical Center

Enrollment

180 participants

Start Date

Jul 24, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating heart disease in people — particularly women — who have chest pain and signs of reduced blood flow to the heart but no major blockages in their coronary arteries. Researchers believe these patients may be at risk for heart failure where the heart pumps normally but is too stiff to fill properly. The study uses specialized cardiac MRI testing. **You may be eligible if...** - You are over 18 years old - You are undergoing a coronary angiogram for suspected chest pain or reduced blood flow, but without major blockages found - Your heart pumping function is at least 45% - You are able to have a cardiac MRI (no metal in chest, no severe claustrophobia, no angioedema) **You may NOT be eligible if...** - You have severe or chronic kidney disease or acute kidney injury - You are allergic to animal dander (the MRI facility is shared with animal imaging) - You have had four or more prior MRI scans using gadolinium contrast dye - You have an allergy to gadolinium contrast Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of Florida

Gainesville, Florida, United States

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NCT03876223


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