Actively Recruiting

Age: 18Years +
All Genders
NCT03876223

Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF

Led by Cedars-Sinai Medical Center · Updated on 2025-07-01

180

Participants Needed

2

Research Sites

344 weeks

Total Duration

On this page

Sponsors

C

Cedars-Sinai Medical Center

Lead Sponsor

U

University of Florida

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Symptomatic men and women undergoing invasive coronary angiography for suspected ischemia with no obstructive coronary artery disease (50% or less narrowing in one or more epicardial coronary arteries)
  • Preserved left ventricular ejection fraction of 45% or higher
  • Ability to safely undergo cardiac MRI (no metal chest devices, no claustrophobia, no angioedema)
  • Competent to provide informed consent
Not Eligible

You will not qualify if you...

  • Severe or chronic kidney disease with GFR less than 40 or acute kidney injury
  • Allergy to animal dander
  • Having had four or more prior gadolinium contrast scans
  • Allergy or hypersensitivity to adenosine, gadolinium, aminophylline, or regadenoson
  • Second- or third-degree atrioventricular block
  • Sinus node disease such as sick sinus syndrome or symptomatic bradycardia (except if with an artificial pacemaker)
  • Mild to severe asthma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

2

University of Florida

Gainesville, Florida, United States, 32610

Actively Recruiting

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Research Team

N

Nicole Tovar

CONTACT

L

Lorena Guzman

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF | DecenTrialz