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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

• Measurable plaque with total plaque volume \>0mm3; women without significant plaque will not receive additional radiation, and we can detect measurable changes in plaque burden and plaque composition.

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Damini Dey, PhD
damini.dey@cshs.org
310 423-1517
Time Frame
Start Date: 2020-07-01
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 204
Treatments
CT Coronary Angiogram with quantitative characterization of plaque
Participants (102) from Intensive Medical Therapy \[IMT\] and 102 from the Usual Care \[UC\] group in the WARRIOR trial) will undergo CTA at the Year 3 follow-up visit (can be as early as 2 years from randomization) at their respective enrollment study sites. Quantitative characterization of plaque analysis will be conducted at Cedars-Sinai Medical Center using Autoplaque plaque analysis software.
Related Therapeutic Areas
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov