NCT05819814

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
12mo left

Started Dec 2023

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
active not 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 Progress71%
Dec 2023Jul 2027

First Submitted

Initial submission to the registry

April 6, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

December 7, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

3.5 years

First QC Date

April 6, 2023

Last Update Submit

June 10, 2026

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseasePolygenic risk scoreGeneticsGenomic medicinePrecision medicinePreventive cardiologyRisk predictionCardiovascular healthCoronary CT angiogramCoronary plaqueAtherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Assess 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.

    1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive their high polygenic risk result for coronary artery disease.

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

Control

NO INTERVENTION

Participants will receive standard of care, and disclosure of high polygenic risk result will be deferred until study completion.

Interventions

Disclosure of high polygenic risk result for coronary artery diseaseBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseGenetic Risk ScoreAtherosclerosis

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 19, 2023

Study Start

December 7, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)