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.
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 coronary artery disease at baseline, and the other group will receive their result after study completion at 1 year. Change in cardiovascular health as measured by the American Heart Association Life's Essential 8 score from baseline to one-year will be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
200
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGAssess the impact of disclosing a high polygenic risk result for coronary artery disease on change in cardiovascular health
Change in cardiovascular health from baseline to one year as measured by the American Heart Association's Life's Essential 8 (LE8) Score will be compared between an intervention arm that receives a high polygenic risk result for coronary artery disease and a control group that receives standard of care. The LE8 score ranges between 0 and 100 with higher numbers indicating better cardiovascular health.
Time frame: 1 year
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