NCT07087431

Brief Summary

The goal of this clinical trial is to evaluate whether disclosure of a polygenic risk score for coronary artery disease (CAD PRS) influences cardiovascular health and risk factor modification over one year among adults aged 30-75 years in the Mass General Brigham primary care network who are not currently taking LDL cholesterol-lowering medications.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
14mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Oct 2025Aug 2027

First Submitted

Initial submission to the registry

July 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2027

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

July 20, 2025

Last Update Submit

March 19, 2026

Conditions

Coronary Artery Disease

Keywords

Polygenic riskAtherosclerosisGeneticsGenomic medicinePolygenic scorePrecision medicinePreventive cardiologyPolygenic risk scoreCAD PRS

Outcome Measures

Primary Outcomes (1)

  • Change in low-density lipoprotein cholesterol (LDL-C) from baseline to 12 months

    The primary outcome is the change in low-density lipoprotein cholesterol (LDL-C) from baseline to 12 months. LDL-C values will be obtained from clinical measurements recorded in the electronic health record. The analysis will compare the change in LDL-C between participants randomized to immediate disclosure versus deferred disclosure of CAD PRS results.

    12 months

Secondary Outcomes (6)

  • Change in Life's Essential 8 (LE8) score from baseline to 12 months

    12 months

  • Completion of lipid panel and blood pressure measurement within 12 months

    12 months

  • Attendance at primary care visit within 12 months

    12 months

  • Initiation of preventive therapies within 12 months

    12 months

  • Change in individual LE8 behavioral components from baseline to 12 months

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Immediate Disclosure

EXPERIMENTAL

Participants are randomized to receive their CAD PRS results after genotyping.

Behavioral: Immediate disclosure of CAD PRS results

Deferred Disclosure

ACTIVE COMPARATOR

Participants are randomized to have their CAD PRS results withheld until approximately 12 months after enrollment.

Behavioral: Deferred Disclosure of CAD PRS results

Interventions

Immediate disclosure of CAD PRS resultsBEHAVIORAL

Participants receive their CAD PRS results as soon as they are available after genotyping.

Immediate Disclosure
Deferred Disclosure of CAD PRS resultsBEHAVIORAL

Participants receive their CAD PRS results after completion of the 12 month follow up period.

Deferred Disclosure

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current age 30-75 years
  • Established primary care at Mass General Brigham with at least one visit in the last 2 years

You may not qualify if:

  • \- Currently taking LDL cholesterol- lowering medications, including statins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseAtherosclerosisGenetic Risk Score

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGenetic Predisposition to DiseaseDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Roukoz Karam, MD

CONTACT

6174121147proact@mgb.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Single-center, parallel-group, randomized clinical trial with two arms: immediate disclosure of coronary artery disease polygenic risk score (CAD PRS) results versus deferred disclosure after approximately 12 months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

July 20, 2025

First Posted

July 28, 2025

Study Start

October 15, 2025

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

August 15, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Data will be tabulated and analyzed. Study site will not share any of the subject identifiers.

Locations

US(1)