RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-07-24
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03876223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Nicole Tovar
CONTACT
310-248-6960
nicole.tovar@cshs.org
Lorena Guzman
CONTACT
3102486960
lorena.guzman@cshs.org

Principal Investigator

C. Noel Bairey Merz, MD, FACC
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of Florida
Gainesville, Florida, 32610
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • C. Noel Bairey Merz, MD, FACC, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-24
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2019-07-24
Study Completion Date2025-02-28

Terms related to this study

Keywords Provided by Researchers

  • Coronary Microvascular Dysfunction (CMD)
  • Coronary Vascular Dysfunction (CVD)
  • Coronary angiography
  • Magnetic resonance imaging (MRI)

Additional Relevant MeSH Terms

  • Coronary Microvascular Dysfunction
  • Heart Failure With Preserved Ejection Fraction (HFpEF)