Assessing the impact of genetic risk information on heart health
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health
This study is testing if sharing genetic risk information for heart disease with people aged 40 to 75 can help them improve their heart health over a year compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05819814 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates whether revealing a high polygenic risk score for coronary artery disease improves cardiovascular health over one year compared to standard care. Participants aged 40 to 75 with high genetic risk but no known cardiovascular disease will be randomly assigned to receive their risk results either at the start or after one year. The study will measure changes in cardiovascular health using the American Heart Association Life's Essential 8 score. The goal is to determine if knowledge of genetic risk can lead to better health outcomes.
Who should consider this trial
Good fit: Ideal candidates are middle-aged individuals aged 40 to 75 with a high polygenic risk score for coronary artery disease and no known cardiovascular disease.
Not a fit: Patients with a history of cardiovascular disease or those with quantifiable plaque on coronary computed tomography angiography may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health management for individuals at high genetic risk for coronary artery disease.
How similar studies have performed: Other studies have shown promising results in using genetic risk information to influence health behaviors, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Roukoz Abou-Karam, MD
- Email: proact@mgb.org
- Phone: (617)-643-4842
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.