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Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health
RECRUITINGN/ASponsored by Massachusetts General Hospital
Actively Recruiting
PhaseN/A
SponsorMassachusetts General Hospital
Started2023-12-07
Est. completion2026-05-01
Eligibility
Age40 Years – 75 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05819814
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.
Eligibility
Age: 40 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria: * 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 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
Conditions2
Coronary Artery DiseaseHeart Disease
Locations1 site
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Actively Recruiting
PhaseN/A
SponsorMassachusetts General Hospital
Started2023-12-07
Est. completion2026-05-01
Eligibility
Age40 Years – 75 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05819814