Prospective Electronic Polygenic Risk Study (PEPRS1)

Scripps Translational Science Institute

Status: Not yet enrolling

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05072275

IRB-21-7762

Details and patient eligibility

About

This study will investigate the role of polygenic risk scores (PRS) in preventive health.

Full description

This study will investigate the role of polygenic risk scores (PRS) in preventive health. Specifically, the purpose of this study is to determine whether knowledge of the degree of coronary artery disease (CAD) genetic risk, as measured and conveyed by a PRS, influences patient and physician decision-making during short-term (6 month) and long-term (2 year) follow-up. The initial findings of this study will be used to plan an expanded second phase study with the purpose of prospectively validating that these decision-making changes lead to improvements in clinical outcomes.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 45 ≥ Age < 65
• ASCVD Risk Score > 7.5% as defined by the standard pooled cohort equation
• Access to and ability to use a smartphone

Exclusion criteria

• Prior diagnosis of coronary disease as defined by prior myocardial infarction (STEMI or NSTEMI), or revascularization (stent or coronary artery bypass grafting)
• Cerebrovascular disease with history of ischemic stroke, TIA, carotid endarterectomy, carotid artery stenting
• Peripheral arterial disease with history of claudication, revascularization (stents or bypass)
• Current and active high-intensity statin prescription (rosuvastatin 20 mg, rosuvastatin 40 mg, atorvastatin 40 mg and atorvastatin 80 mg)
• Anti-PCSK9 therapy
• Lipid apheresis therapy
• Currently enrolled in a clinical trial for lipid lowering therapy
• Known statin intolerance to 2 or more statins in the past

Trial design

1,000 participants in 1 patient group

Subjects receiving care from Scripps Health physicians in Cardiology and Primary Care

Description:

A confidential data request will be submitted to screen the Scripps Health EHR system for individuals meeting study inclusion criteria and having seen a participating study physician in the past two years.