Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program

Study Overview
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Brief Summary
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This study will evaluate the effectiveness of an individualized approach to diagnosing and/or treating atherosclerosis. This will be done by combining genetic information, lifestyle information, participant education, and imaging tests to track diagnoses, therapies, and treatment on two groups: 1) Standard Management Group (diagnosed and/or treated according to standard of care) and 2) Individualized Management Group (standard of care plus genetic testing and coronary artery calcium scans).

Detailed Description
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The purpose of this proposal is to create a large, community-based demonstration project to evaluate the value of a highly individualized approach to atherosclerosis risk reduction. In this project we set out to compare the delivery of appropriate therapies and resource utilization using current national guidelines for the management of atherosclerosis and will compare this to using a highly individualized approach for atherosclerosis risk reduction, based on the evaluation of specific features in individuals and tailoring management based on this evaluation. We plan to show that utilizing the iCARE Program, more patients will receive appropriate diagnoses and subsequent therapies in a more efficient manner.

Official Title
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Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program

Conditions
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Atherosclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No known coronary artery disease no prior coronary disease by cardiac catheterization (≤39% in any major epicardial vessel) no prior myocardial infarction no prior ST-elevation myocardial infarction (1 mm ST-elevation in 2 contiguous leads) no prior non-ST-elevation myocardial infarction (CK-MB > 2x ULN or elevated troponin that is indicative of myocardial necrosis based on local institutional cutpoints) no prior coronary revascularization procedure Intermediate or high Framingham Risk Score (10-year risk 10% or greater) Ability and willingness to provide consent and Authorization for use of PHI Exclusion Criteria: Presence of known cardiomyopathy Presence of permanent pacemaker, defibrillator, or CRT device Presence of clinically significant, uncontrolled arrhythmia (chronic or paroxysmal atrial fibrillation is NOT an exclusion. Arrhythmias treated successfully with ablation are not an exclusion. Presence of a known genetic abnormality of cholesterol metabolism (e.g. familial hypercholesterolemia) Inability or unwillingness to adhere to follow up schedule Inability or unwillingness to provide informed consent and Authorization for use of PHI

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individualized Managment Group<br>Participants receiving, in addition to standard of care, blood tests for markers of heart disease, DNA and RNA analysis, and coronary artery calcium scan. | |
| Standard Management Group<br>Participants who receive standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the proportion of subjects and patients who are diagnosed with subclinical and clinically significant coronary atherosclerosis with the PHI-ACE-iCARE approach, compared to the current guideline-driven approach. |  | 6 months, 12 months, 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the proportion of patients who receive appropriate revascularization procedures for clinically significant coronary atherosclerosis with the PHI-ACE-iCARE approach, compared to the current guideline-driven approach. |  | 6 month, 12 months, 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis