RECRUITING

WARRIOR Ancillary Study for CCTA Analysis

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

In this study, quantitative characterization of plaque using coronary computed tomographic angiography (CTA) will be used to determine if women who were treated with intensive medical therapy have a greater reduction in the amount and type of cholesterol plaque compared to women receiving usual care and if this results in beneficial changes in clinical symptoms. The study will provide an understanding of how intensive medical therapy works in providing clinical benefit in women with nonobstructive plaque.

Official Title

Effect of Intensive Medical Treatment on Quantified Coronary Artery Plaque Components With Serial Coronary CTA in Women With NonObstructive CAD

Quick Facts

Study Start:2020-07-01
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05035056

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:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * In addition to the inclusion criteria of the WARRIOR trial, only women who meet the following criteria will undergo final CTA at the same sites where they are screened and enrolled.
  2. * Initial CTA with excellent or good image quality-defined as images where we are able to clearly identify the atherosclerotic plaque. Based on our preliminary assessment, we expect 90% of studies to be included.
  3. * Measurable plaque with NCP volume ≥ 200mm3; women without significant plaque will not receive additional radiation, and we can detect measurable changes in plaque burden and plaque composition.
  1. * In addition to exclusion criteria of the parent WARRIOR trial, key exclusion criteria are:
  2. * Non-adherent with IMT. The parent trial is already powered for non-adherence. In our ancillary trial we have built in an exclusion, from final analysis, of an additional 30% who may be nonadherent with IMT or UC.

Contacts and Locations

Study Contact

Damini Dey, PhD
CONTACT
310 423-1517
damini.dey@cshs.org

Principal Investigator

Damini Dey, PhD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Balaji Tamarappoo, MD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Damini Dey, PhD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center
  • Balaji Tamarappoo, MD, PRINCIPAL_INVESTIGATOR, Indiana University

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 Date2020-07-01
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2020-07-01
Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Coronary Artery Disease
  • Non-Obstructive Coronary Atherosclerosis
  • Ischemia