🏛️ Verified NIH Record • Updated 2026-06-10
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health (NCT05819814)
🔵 Active, Not Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: Massachusetts General Hospital
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (12 items).
Location: Massachusetts General Hospital — Boston, Massachusetts
Age range: 40 Years to 75 Years
🧪 Interventions in This Study
- Disclosure of high polygenic risk result for coronary artery disease (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Massachusetts General Hospital — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Coronary Artery Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.