NCT03876223Recruiting
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)
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 180 (estimated)
- First submitted
- 22 Feb 2019
- Start date
- 24 Jul 2019
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Heart failure
- NCT number
- NCT03876223
What you commit to
- Study type: Observational
- Planned participants: 180
- From 24 Jul 2019 to the primary completion date, 28 Feb 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
Related publications
- The "Brain's Traffic Map" Reveals Neural Pathways Linked to Coronary Microvascular Dysfunction in Women.Brain Behav · 2026 · PMID 42348298
This page is information, not medical advice. Discuss any trial with your doctor.