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Search / Trial NCT06542432

Utility and Effectiveness of Polygenic Risk Scoring (PRS) for Coronary Artery Disease (CAD)

Launched by MYOME · Aug 5, 2024

Trial Information

Current as of June 27, 2025

Enrolling by invitation

Keywords

Polygenic Risk Score Integrated Risk Score Genetics Cardiovascular Health Coronary Artery Disease Precision Medicine

ClinConnect Summary

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 enrollm...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • ASCVD risk ≥5% and below 20% over the following 10 years as defined by the standard pooled cohort equations
  • No previous CAD event (inclusive of myocardial infarction, diagnosis of CAD, stroke)
  • Previously genotyped as part of a research study that enables recontact of participants
  • Receiving primary care at a participating institution.
  • Exclusion Criteria:
  • Prior diagnosis of CAD: inclusive of prior myocardial infarction and revascularization (stent or coronary artery bypass grafting)
  • Currently treated with lipid-lowering therapy, including statins, ezetimibe, PCSK9 inhibitors, inclisiran, or bempedoic acid
  • Future use of statins contraindicated
  • Prior diagnosis of Cerebrovascular disease: Inclusive of history of ischemic stroke, transient ischaemic attack (TIA), carotid endarterectomy, carotid artery stenting
  • Prior diagnosis of Peripheral arterial disease: Inclusive of history of claudication, revascularization (stents or bypass)
  • Severe hypercholesterolemia (LDL-C ≥ 190 mg/dL)

About Myome

Myome is a leading clinical trial sponsor dedicated to advancing women's health through innovative research and development. Specializing in therapies for reproductive health and related conditions, Myome leverages cutting-edge science and a patient-centered approach to drive the discovery of effective treatments. With a commitment to rigorous clinical standards and ethical practices, Myome collaborates with healthcare professionals and research institutions to enhance the quality of life for women worldwide. Through its strategic initiatives, Myome aims to bridge the gap between laboratory innovation and real-world applications, ensuring that new therapies are both safe and beneficial for patients.

Locations

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported