Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health
Massachusetts General Hospital
Summary
The goal of this randomized controlled trial is to assess the impact of disclosing a high polygenic risk result for coronary artery disease on change in cardiovascular health over one year.
Description
The main question PROACT 1 aims to answer is whether cardiovascular health improves following disclosure of high polygenic risk result for coronary artery disease compared to standard of care. This is a 1:1 randomized controlled trial of middle-aged participants with no known cardiovascular disease, are not on lipid-lowering therapy, who have high polygenic risk score for coronary artery disease, and do not have quantifiable plaque on coronary computed tomography angiography. Participants will be randomized into two equal groups: one group will receive their high polygenic risk result for cor…
Eligibility
- Age range
- 40–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Males and females between 40 and 75 years of age capable and willing to provide informed consent * Participant has high CAD PRS as defined on a clinical test Exclusion Criteria: * Participant with a history of cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease * Participant with quantifiable plaque on a coronary computed tomography angiography * Participant with a history of Liver disease (cirrhosis, active hepatitis, or severe hepatic disease) or any of the following recent lab results and d…
Interventions
- BehavioralDisclosure of high polygenic risk result for coronary artery disease
The disclosure of a high polygenic risk result for coronary artery disease involves a clinical report coupled with a virtual meeting with a genetic counselor.
Location
- Massachusetts General HospitalBoston, Massachusetts