An interventional study of Disclosure of integrate risk score for coronary artery disease in Coronary Artery Disease, Polygenic Risk Score and Heart Diseases, sponsored by MyOme. Enrolling by invitation at 2 sites in United States. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by MyOme · Not applicable, Interventional, and Prevention
The goal of this study is to assess the benefit to physicians and patients of adding an integrated risk score (IRS) to existing coronary artery risk tools by conducting a randomized prospective study. IRS combines both an individual's coronary artery disease (CAD) polygenic risk score (PRS) and clinical risk factors, like cholesterol levels and age. This study will examine to what extent IRS knowledge impacts physician/provider behavior as well as clinical outcomes including cholesterol levels and incident heart disease.
This is a 1:1 randomized controlled trial of participants with no known coronary artery disease, are not on lipid-lowering therapy, and do not have LDL-C over 190mg/dL. Participants will be recruited from cohorts that have been previously genotyped and found to have either elevated or average risk based on a CAD IRS. Participants will be randomized into two equal groups: one group will receive their IRS result for coronary artery disease at baseline, and the other group will receive their ASCVD Pooled Cohorts Equation result at baseline and CAD IRS result approximately 3 years after enrollment. Subject data will be collected for 5 years from the time of enrollment.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →This is the only study on the registry with MyOme as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive their integrated risk score result for coronary artery disease.
Genetic: Disclosure of integrate risk score for coronary artery disease
Participants will only receive standard of care ASCVD Pooled Cohorts Equation (ASCVD PCE), and disclosure of integrated risk score result will be deferred until 3 years after enrollment.
Participants will receive their integrated risk score for coronary disease along with an optional genetic counseling visit to discuss the results.
Does receiving an IRS report influence clinical decision making, including the provider's decision to treat with lipid lowering medication or order diagnostic testing?
Aggregating longitudinal clinical data will be collected to compare the incidence of lipid-lowering medication initiation and cardiac diagnostic testing between the intervention arm which received their integrated risk score and the control group.
Time frame: 5 years
Does receiving an IRS report affect patient clinical measurements, including LDL-C levels?
Aggregating longitudinal clinical data will be collected to compare the clinical measurements between the intervention arm which received their integrated risk score and the control group.
Time frame: 5 years
Does the IRS identify those at elevated risk for CAD and future ASCVD events?
Aggregated longitudinal clinical data and patient survey data will be collected to compare patient clinical outcomes in those with a high CAD IRS.
Time frame: 5 years
Does receiving an IRS report affect the incidence of CAD events?
Aggregated longitudinal clinical data will be collected to compare patient clinical outcomes in those with a CAD IRS reported at baseline and the control group.
Time frame: 5 years
Does receiving an IRS report affect participant understanding of their individual CAD risk?
Patient survey data will be collected to assess their understanding of their CAD risk.
Time frame: 5 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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