RECRUITING

Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine

Conditions

Coronary Artery Disease Polygenic risk Atherosclerosis Genetics Genomic medicine Polygenic score Precision medicine Preventive cardiology Coronary plaque Inflammation Cholesterol Lipids Colchicine Statin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this double-blind randomized controlled trial is to determine how treatment with high intensity statin, low-dose colchicine, and their combination modulates progression and composition of coronary atherosclerosis in individuals with high polygenic risk for coronary artery disease.

Official Title

Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine

Quick Facts

Study Start:2023-12-07

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05850091

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.

Ages Eligible for Study:40 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 subclinical atherosclerosis defined as plaque visible on CCTA and causing \<70% luminal stenosis	* Participant with a history of cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease * 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

Inclusion Criteria

Exclusion 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 subclinical atherosclerosis defined as plaque visible on CCTA and causing \<70% luminal stenosis

* Participant with a history of cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
* 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

Contacts and Locations

Study Contact

Fangzhou Cheng

CONTACT

(617)-643-4842

proact@mgb.org

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-07

Study Completion Date2027-07

Study Record Updates

Study Start Date2023-12-07

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

Polygenic risk
Atherosclerosis
Genetics
Genomic medicine
Polygenic score
Precision medicine
Preventive cardiology
Coronary plaque
Inflammation
Cholesterol
Lipids
Colchicine
Statin

Additional Relevant MeSH Terms

Coronary Artery Disease