Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health
Running, not enrolling · Not applicable
Conditions studied: Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT05819814
- Run by
- Massachusetts General Hospital
- People needed
- 200
- Starts
- 2023-12-07
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-06-12
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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