- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05035056
WARRIOR Ancillary Study for CCTA Analysis
Effect of Intensive Medical Treatment on Quantified Coronary Artery Plaque Components With Serial Coronary CTA in Women With NonObstructive CAD
Study Overview
Status
Detailed Description
This is an ancillary substudy of the WARRIOR Trial (NCT03417388), a multi-site, PROBE design, that will evaluate an intensive statin/ACE-I (or ARB)/aspirin treatment strategy (IMT) vs. primary prevention risk factor therapy treatment strategy (UC) in 4,422 symptomatic (chronic angina or equivalent) women with non-obstructive CAD (<50% diameter narrowing).
In this ancillary substudy, 204 patients will be recruited from the WARRIOR trial with 102 patients from each of the treatment groups (IMT vs UC). From this cohort, 102 patients per treatment group, most compliant with WARRIOR protocol will undergo a CTA from any time from 2 years post-baseline up to the end of the main WARRIOR study; with changes in plaque and PCAT characteristics quantified.
The main aims are as follows:
- To compare changes in coronary plaque characteristics and their hemodynamic significance using CTA in WARRIOR women treated with IMT vs UC;
- To compare changes in plaque inflammation-related characteristics in PCAT in WARRIOR women treated with IMT with statin in combination with angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) medications vs UC;
- To relate plaque burden and plaque composition, CT flow reserve, and PCAT density changes to angina score (Seattle Angina Questionnaire [SAQ]) changes in IMT and UC-randomized WARRIOR women.
Data to be analyzed include CT angiography scans at baseline and Year 3 follow-up and corresponding study data and laboratory tests (e.g. hsCRP); plus, selected data from the main WARRIOR study that are relevant to the present ancillary study.
UPDATE; In this ancillary study, 204 patients will be recruited from the WARRIOR Trial with 102 patients from each of the treatment groups (IMT vs UC). From this cohort, 102 patients per treatment group, most compliant with WARRIOR protocol will undergo a CTA as early as 2 years after their WARRIOR baseline scan up to study completion; with changes in plaque and CAT characteristics quantified.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Damini Dey, PhD
- Phone Number: 310 423-1517
- Email: damini.dey@cshs.org
Study Locations
-
-
California
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Los Angeles, California, United States, 90048
- Recruiting
- Cedars-Sinai Medical Center
-
Contact:
- Damini Dey, PhD
- Phone Number: 310-423-1517
- Email: damini.dey@cshs.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 NCP volume ≥ 200mm3; women without significant plaque will not receive additional radiation, and we can detect measurable changes in plaque burden and plaque composition.
Exclusion Criteria:
- In addition to exclusion criteria of the parent WARRIOR trial, key exclusion criteria are:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
CT Coronary Angiogram with quantitative characterization of plaque
Participants (103) from Intensive Medical Therapy [IMT] and 103 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) at their respective enrollment study sites.
Quantitative characterization of plaque analysis will be conducted at Cedars-Sinai Medical Center using Autoplaque plaque analysis software.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in atherosclerotic plaque burden and noncalcified plaque composition
Time Frame: 3 years
|
Change in atherosclerotic plaque burden (%) and noncalcified plaque composition (%) using Autoplaque plaque analysis software
|
3 years
|
Change in coronary plaque inflammation (measured as CT attenuation of Pericoronary adipose tissue)
Time Frame: 3 years
|
Change in pericoronary artery adipose tissue (PCAT) density (CT attenuation of PCAT, in Hounsfield Units) by Autoplaque plaque analysis software
|
3 years
|
Change in angina score assessed by the Seattle Angina Questionnaire (SAQ)
Time Frame: 3 years
|
Change in angina score quantified by the Seattle Angina Questionnaire (SAQ)
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Damini Dey, PhD, Cedars-Sinai Medical Center
- Principal Investigator: Balaji Tamarappoo, MD, Indiana University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000896
- 1R01HL151266 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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