Prospective Electronic Polygenic Risk Study

Not yet recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT05072275
• Lead Sponsor: Scripps Translational Science Institute

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-08
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-07
• Study Start: 2023-03
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Statin or other lipid lowering therapy initiation or intensification by EHR entry	6 months post enrollment	New or intensified prescriptions for statins or other LDL lowering therapy. Binary outcome measured at 6-months post-enrollment by survey-based self-report and EHR analysis - encoded as 0 if no new or intensified prescription relative to medication status at baseline, and 1 if a new or intensified prescription is entered in the EHR relative to medication status at baseline. A prescription for statins or other LDL lowering therapy is considered new if an EHR entry for a statin, PCSK9i, or ezitimibe is present at follow-up and no equivalent EHR entry exists for up to 1-year prior to enrollment. A statin prescription is considered intensified if an active statin prescription is present in the EHR at enrollment and an active statin prescription of a higher intensity tiers (high-, moderate-, and low-intensity) as described in the 2013 ACC/AHA Guidelines on the Treatment of Blood Cholesterol is present at follow-up.

Secondary Outcome Measures

Name	Time	Method
Adequate LDL-C lowering - comparison of baseline and follow-up measures by lab test	6 months and 2 years post enrollment	Adequate LDL-C lowering. Adequate LDL-C lowering is defined as 30% or more reduction from baseline study measured LDL-C
Statin or other lipid lowering therapy adherence by EHR entry	2 years post enrollment	Statin or other lipid lowering therapy prescription possession. Binary outcome measured at 2-years post-enrollment by EHR entry. Statin adherence is defined as prescription coverage of no less than 80% of the days between the index statin prescription and the end of the 2-year follow-up period
Statin or other lipid lowering therapy persistence by EHR entry	2 years post enrollment	Statin or other lipid lowering therapy prescription renewal. Binary outcome measured at 2-years post-enrollment by EHR analysis. Statin persistence is defined as prescription renewal within 60 days of the end of the duration of an index statin prescription made after study enrollment
Lifestyle changes by survey	6 months post enrollment	Adoption of Healthy Lifestyle. Binary outcomes derived from baseline and 6-months post-enrollment by survey-based self-report.
Physician Utility by survey	6 months and 1 year	Physician confidence, perceived utility, and actions attributable to genomic testing.