Prospective Electronic Polygenic Risk Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2027-01-15

Brief Summary

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

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Detailed Description

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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 or glaucoma genetic risk, as measured and conveyed by a PRS, influences patient and physician decision-making as well as clinical outcomes during short-term (6-month / 2-year) and long-term (3-year / 5-year) follow-up. A CAD and glaucoma PRS will be calculated for all study participants, with participants randomized to receiving either their CAD or glaucoma PRS. This study design allows for causal attribution of preventive actions and clinical outcomes to the receipt and degree of genetic risk. The design is informed by a pilot (MyGeneRank) and phase 1 (PEPRS first phase) study, with the key extensions being the addition of randomization and increasing the study population size to power causal association with long-term, hard clinical outcomes.

Conditions

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Coronary Artery Disease Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Subjects identified by Optum Health

10,000 individuals identified by Optum Health as likely meeting inclusion criteria by claims analysis.

Group Type EXPERIMENTAL

Genetic risk assessment

Intervention Type BEHAVIORAL

A coronary artery disease (CAD) and glaucoma polygenic risk scores (PRS) will be calculated for all study participants, with participants randomized to receiving either their CAD or glaucoma PRS.

Interventions

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Genetic risk assessment

A coronary artery disease (CAD) and glaucoma polygenic risk scores (PRS) will be calculated for all study participants, with participants randomized to receiving either their CAD or glaucoma PRS.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
* Prior diagnosis or treatment of glaucoma
* 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

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No