Actively Recruiting
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health
Led by Massachusetts General Hospital · Updated on 2026-03-23
200
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- History of cardiovascular disease including coronary artery disease, peripheral artery disease, or cerebrovascular disease
- Presence of quantifiable plaque on coronary computed tomography angiography
- History of liver disease such as cirrhosis, active hepatitis, or severe hepatic disease, or recent abnormal liver lab tests not due to Gilbert syndrome
- Estimated glomerular filtration rate below 60 mL/min/1.73 m2 or creatinine greater than twice the upper limit of normal
- History of allergic reaction or sensitivity to iodinated contrast, colchicine, or statins
- Current use of LDL cholesterol lowering or anti-inflammatory medications including colchicine
- Use of regular drugs that are potent CY2P inhibitors (e.g., ketoconazole, clarithromycin)
- Female who is pregnant, breastfeeding, or considering pregnancy during the study
- Body mass index of 40 kg/m2 or higher
- Unable to provide informed consent
- Unable to hold breath for 10 seconds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
R
Roukoz Abou-Karam, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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