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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05819814

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

600

Enrollment

Location

Arms

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this non-randomized controlled trial is to assess the impact of disclosing a high polygenic risk result for coronary artery disease and subsequent screening to detect subclinical coronary atherosclerosis on change in cardiovascular health over one year.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Genetic: Polygenic risk-based detection of subclinical coronary atherosclerosis	N/A

Detailed Description

The main question PROACT 1 aims to answer is whether cardiovascular health improves following polygenic risk-based detection of subclinical coronary atherosclerosis paired with education compared to education alone without knowledge of polygenic risk or subclinical coronary atherosclerosis.

This is a non-randomized controlled trial, which will compare two groups from an existing pool at Mass General Brigham (MGB) that has been screened for eligibility requirements. Middle-aged participants of the MGB Biobank who have high polygenic risk score for coronary artery disease will be compared to matched controls from MGB Primary Care. Both groups will receive the American Heart Association's Life's Essential 8 cardiovascular health education fliers. The MGB Biobank group will additionally receive a high polygenic risk result for coronary artery disease and be invited to participate in a coronary computed tomographic angiography study to identify subclinical coronary artery disease. Change in Life's Essential 8 score from baseline to one-year will be compared.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2026

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MGB Biobank Participants will receive their high polygenic risk result for coronary artery disease and a coronary computed tomography angiography to detect subclinical atherosclerosis in addition to cardiovascular health education fliers.	Genetic: Polygenic risk-based detection of subclinical coronary atherosclerosis Disclosure of a high polygenic risk result followed by screening for subclinical coronary atherosclerosis using coronary computed tomography angiography.
No Intervention: MGB Primary Care Participants will only receive cardiovascular health education fliers.

Arm

Intervention/Treatment

Experimental: MGB Biobank

Participants will receive their high polygenic risk result for coronary artery disease and a coronary computed tomography angiography to detect subclinical atherosclerosis in addition to cardiovascular health education fliers.

Genetic: Polygenic risk-based detection of subclinical coronary atherosclerosis

Disclosure of a high polygenic risk result followed by screening for subclinical coronary atherosclerosis using coronary computed tomography angiography.

No Intervention: MGB Primary Care

Participants will only receive cardiovascular health education fliers.

Outcome Measures

Primary Outcome Measures

Assess the impact of polygenic risk-based detection of subclinical atherosclerosis on change in cardiovascular health [1 year]
Change in cardiovascular health from baseline to one year as measured by the American Heart Association's Life's Essential 8 Score will be compared between an intervention arm that undergoes polygenic-risk based detection of subclinical atherosclerosis and a matched control group.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

High polygenic risk result for coronary artery disease (MGB biobank)

Exclusion Criteria:

Cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
Taking LDL cholesterol lowering or anti- inflammatory medications
Contraindications to coronary computed tomography angiography (chronic kidney disease, contrast allergy)
Pregnancy or breastfeeding
Inability to provide informed consent