Status:
RECRUITING
Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
University of Florida
Conditions:
Coronary Microvascular Dysfunction
Heart Failure With Preserved Ejection Fraction (HFpEF)
Eligibility:
All Genders
18+ years
Brief 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 contrib...
Detailed Description
Coronary microvascular dysfunction (CMD) due to changes in the function and structure of coronary microcirculation in the absence of obstructive coronary artery disease (CAD) is poorly understood. Isc...
Eligibility Criteria
Inclusion
- Inclusion:
- 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.
- Preserved left ventricular ejection fraction (EF) ≥45%
- Be \> 18 years old
- Be able to meet the requirement for a cardiac MRI, which means no metal devices in your chest, no claustrophobia and no angioedema
- Be competent to give informed consent
- Exclusion:
- Subjects with severe or chronic kidney disease (CKD) with GFR\<405 or acute kidney injury
- Subjects with allergy to animal dander will be excluded since imaging will be done in BIRI (BIRI scanners are also used to image animals).
- Subjects who have had four or more prior previous gadolinium contrast scans
- Allergy/ hypersensitivity to adenosine, gadolinium, aminophylline or regadenoson
- Second- or third-degree A-V block
- Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker)
- Subjects with mild to severe asthma
Exclusion
Key Trial Info
Start Date :
July 24 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03876223
Start Date
July 24 2019
End Date
February 28 2026
Last Update
July 1 2025
Active Locations (2)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of Florida
Gainesville, Florida, United States, 32610