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

Description

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.

Conditions

Coronary Artery Disease

Study Overview

Study Details

Study overview

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.

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

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

Condition
Coronary Artery Disease
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

40 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Study Record Dates

2027-07