RecruitingNot ApplicableNCT05819814

Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health


Sponsor

Massachusetts General Hospital

Enrollment

200 participants

Start Date

Dec 7, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria2

  • 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 Criteria11

  • 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

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Interventions

BEHAVIORALDisclosure of high polygenic risk result for coronary artery disease

The disclosure of a high polygenic risk result for coronary artery disease involves a clinical report coupled with a virtual meeting with a genetic counselor.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT05819814


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