Women's Ischemia Syndrome Evaluation (WISE) Mechanisms of Coronary Microvascular Dysfunction Leading to Pre-Heart Failure With Preserved Ejection Fraction (HFpEF)

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Florida
University of Florida
RECRUITING
Gainesville
Contact Information
Primary
Nicole Tovar
nicole.tovar@cshs.org
310-248-6960
Backup
Lorena Guzman
lorena.guzman@cshs.org
3102486960
Time Frame
Start Date: 2019-07-24
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 180
Sponsors
Collaborators: University of Florida
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov