NCT03876223 Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF
| NCT ID | NCT03876223 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cedars-Sinai Medical Center |
| Condition | Coronary Microvascular Dysfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2019-07-24 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2019-07-24 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
C. Noel Bairey Merz, MD, FACC
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT03876223 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Microvascular Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03876223 currently recruiting?
Yes, NCT03876223 is actively recruiting participants. Contact the research team at nicole.tovar@cshs.org for enrollment information.
Where is the NCT03876223 trial being conducted?
This trial is being conducted at Los Angeles, United States, Gainesville, United States.
Who is sponsoring the NCT03876223 clinical trial?
NCT03876223 is sponsored by Cedars-Sinai Medical Center. The principal investigator is C. Noel Bairey Merz, MD, FACC at Cedars-Sinai Medical Center. The trial plans to enroll 180 participants.