Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health (PROACT 1)

Mass General Brigham

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Genetic: Disclosure of high polygenic risk result for coronary artery disease

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05819814

2023P000935

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

200 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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 determined to be non-transient: alanine aminotransferase greater than 3 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal (unless due to Gilbert syndrome)
Participant with estimated glomerular filtration rate <60 mL/min/1.73 m2 or creatinine greater than 2 times the upper limit of normal
Patient with history of an allergic reaction or significant sensitivity to iodinated contrast, colchicine, or statins
Patient currently taking LDL cholesterol lowering or anti- inflammatory medications including colchicine
Participants requiring regular drugs known to be potent CY2P inhibitors (eg. ketoconazole, clarithromycin)
Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study
Participant with BMI ≥ 40 kg/m2
Participant unable to provide informed consent
Participant unable to hold breath for 10 seconds