WARRIOR Ancillary Study for CCTA Analysis

Launched by CEDARS-SINAI MEDICAL CENTER · Sep 1, 2021

Keywords

ClinConnect Summary

The WARRIOR Ancillary Study is looking at how well intensive medical therapy can help women with certain heart conditions, specifically those with non-obstructive coronary artery disease. Researchers want to see if this treatment reduces the amount and type of cholesterol plaque in their arteries more effectively than standard care. By using a special imaging technique called coronary computed tomographic angiography (CTA), they will measure changes in plaque and how these changes might improve heart-related symptoms for the women involved.

To participate in this study, women aged 65 to 74 need to have a good-quality initial CTA that shows clear images of their heart's plaque. They should have measurable plaque that meets specific criteria. It’s important to note that women who don’t follow their treatment plan may not be included in the final results. If eligible, participants can expect to have follow-up imaging and assessments to track their progress in response to the treatment. This study aims to provide valuable insights into how targeted medical therapy can benefit women's heart health.

Gender

FEMALE

Eligibility 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 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.
• 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.