Analyzing plaque changes in women with coronary artery disease
Effect of Intensive Medical Treatment on Quantified Coronary Artery Plaque Components With Serial Coronary CTA in Women With NonObstructive CAD
This study is testing how different treatments affect plaque buildup in the arteries of women with coronary artery disease to see if intensive medical therapy works better than standard care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05035056 on ClinicalTrials.gov |
What this trial studies
This study aims to quantitatively characterize plaque using coronary computed tomographic angiography (CTA) to assess the effects of intensive medical therapy versus usual care in women with non-obstructive coronary artery disease. It is an ancillary study to the WARRIOR Trial, involving 204 women who will undergo CTA to evaluate changes in plaque characteristics and their relationship to clinical symptoms over a three-year period. The study will focus on comparing plaque burden, composition, and inflammation-related characteristics between the two treatment groups.
Who should consider this trial
Good fit: Ideal candidates for this study are women with non-obstructive coronary artery disease who have measurable plaque and are compliant with the treatment protocols.
Not a fit: Patients without significant plaque or those who do not adhere to the treatment protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for women with non-obstructive coronary artery disease, enhancing their clinical outcomes.
How similar studies have performed: Other studies have shown success in using similar imaging techniques to evaluate coronary artery disease, but this specific approach focusing on women with non-obstructive plaque is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Damini Dey, PhD — Cedars-Sinai Medical Center
- Study coordinator: Damini Dey, PhD
- Email: damini.dey@cshs.org
- Phone: 310 423-1517
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.