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

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Polygenic risk-based detection of subclinical coronary atherosclerosis
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Coronary artery disease, Polygenic risk score, Genetics, Genomic medicine, Precision medicine, Preventive cardiology, Risk prediction, Cardiovascular health, Coronary CT angiogram, Coronary plaque, Atherosclerosis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MGB Biobank

MGB Primary Care

Arm Description

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.

Participants will only receive cardiovascular health education fliers.

Outcomes

Primary Outcome Measures

Assess the impact of polygenic risk-based detection of subclinical atherosclerosis 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 Score will be compared between an intervention arm that undergoes polygenic-risk based detection of subclinical atherosclerosis and a matched control group.

Secondary Outcome Measures

Full Information

First Posted
April 6, 2023
Last Updated
April 6, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05819814
Brief Title
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health
Acronym
PROACT 1
Official Title
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Polygenic risk score, Genetics, Genomic medicine, Precision medicine, Preventive cardiology, Risk prediction, Cardiovascular health, Coronary CT angiogram, Coronary plaque, Atherosclerosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MGB Biobank
Arm Type
Experimental
Arm Description
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.
Arm Title
MGB Primary Care
Arm Type
No Intervention
Arm Description
Participants will only receive cardiovascular health education fliers.
Intervention Type
Genetic
Intervention Name(s)
Polygenic risk-based detection of subclinical coronary atherosclerosis
Intervention Description
Disclosure of a high polygenic risk result followed by screening for subclinical coronary atherosclerosis using coronary computed tomography angiography.
Primary Outcome Measure Information:
Title
Assess the impact of polygenic risk-based detection of subclinical atherosclerosis on change in cardiovascular health
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roukoz Abou Karam
Phone
(617)-412-1147
Email
raboukaram@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
Email
afahed@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Akl C Fahed, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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