NCT05175651

Prospective Electronic Polygenic Risk Study - Second Phase

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,000 (estimated)
• Sponsor: Scripps Translational Science Institute · Academic / Other
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

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 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

• Coronary Artery Disease
• Glaucoma

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-01-15
• Completion: 2027-01-15
• First posted: 2022-01-04
• Last updated: 2022-11-07