1000 Participants Needed

Polygenic Risk Scoring for Coronary Artery Disease

LM
Overseen ByLindsay Meyers, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to assess the benefit to physicians and patients of adding an integrated risk score (IRS) to existing coronary artery risk tools by conducting a randomized prospective study. IRS combines both an individual's coronary artery disease (CAD) polygenic risk score (PRS) and clinical risk factors, like cholesterol levels and age. This study will examine to what extent IRS knowledge impacts physician/provider behavior as well as clinical outcomes including cholesterol levels and incident heart disease.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes people who are currently treated with lipid-lowering therapy like statins. This suggests that if you are on such medications, you may not be eligible to participate.

Is polygenic risk scoring for coronary artery disease safe for humans?

The research does not provide specific safety data for polygenic risk scoring, but it discusses its use in predicting coronary artery disease risk and its potential integration with existing medical practices.12345

How does polygenic risk scoring differ from other treatments for coronary artery disease?

Polygenic risk scoring is unique because it uses genetic information to predict an individual's risk of developing coronary artery disease, helping to identify those who might benefit most from preventive treatments. Unlike traditional treatments that focus on managing symptoms or risk factors, this approach aims to enhance risk prediction and personalize prevention strategies.12356

What data supports the effectiveness of the treatment Integrated Risk Score (IRS) for coronary artery disease?

Research shows that polygenic risk scores, which are part of the Integrated Risk Score, can help predict coronary artery disease and identify individuals who might benefit from preventive treatments like statins.12356

Are You a Good Fit for This Trial?

This trial is for individuals with a moderate risk of heart disease in the next 10 years, who have been previously genotyped for research and are receiving care at a participating institution. It's not open to those who've already had a heart-related event like a heart attack or stroke.

Inclusion Criteria

My risk of heart disease or stroke is between 5% and 20% over the next 10 years.
I was genotyped in a study that allows follow-up contact.
I receive my primary care from a participating institution.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants receive their integrated risk score result for coronary artery disease or standard of care ASCVD Pooled Cohorts Equation

1 visit
1 visit (in-person)

Follow-up

Participants are monitored for clinical outcomes and understanding of CAD risk over time

5 years
Annual visits (in-person or virtual)

Deferred Disclosure

Control group receives their integrated risk score result approximately 3 years after enrollment

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Integrated Risk Score (IRS)
Trial Overview The study tests whether adding an integrated risk score (IRS), which combines genetic and clinical factors, to current coronary artery disease risk tools helps doctors make better treatment decisions and improves patient outcomes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental: InterventionExperimental Treatment1 Intervention
Participants will receive their integrated risk score result for coronary artery disease.
Group II: No Intervention: ControlActive Control1 Intervention
Participants will only receive standard of care ASCVD Pooled Cohorts Equation (ASCVD PCE), and disclosure of integrated risk score result will be deferred until 3 years after enrollment.

Find a Clinic Near You

Who Is Running the Clinical Trial?

MyOme

Lead Sponsor

Trials
1
Recruited
1,000+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+

Published Research Related to This Trial

Recent advancements in identifying genetic alleles linked to coronary artery disease have led to improved polygenic risk scores, which can predict the likelihood of developing the disease and inform treatment responses.
The review highlights the importance of careful validation and responsible clinical use of these polygenic risk scores for risk prediction, patient prioritization, and enhancing clinical trial designs.
Clinical utility of polygenic risk scores for coronary artery disease.Klarin, D., Natarajan, P.[2023]

Citations

Clinical utility of polygenic risk scores for coronary artery disease. [2023]
Predictive Accuracy of a Polygenic Risk Score-Enhanced Prediction Model vs a Clinical Risk Score for Coronary Artery Disease. [2021]
Polygenic Risk Score to Identify Subclinical Coronary Heart Disease Risk in Young Adults. [2023]
Limitations of Contemporary Guidelines for Managing Patients at High Genetic Risk of Coronary Artery Disease. [2023]
Polygenic Risk Score-Enhanced Risk Stratification of Coronary Artery Disease in Patients With Stable Chest Pain. [2022]
Taking the next steps to implement polygenic risk scoring for improved risk stratification and primary prevention of coronary artery disease. [2022]
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