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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| Mayo Clinic | OTHER |
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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.
This is a 1:1 randomized controlled trial of participants with no known coronary artery disease, are not on lipid-lowering therapy, and do not have LDL-C over 190mg/dL. Participants will be recruited from cohorts that have been previously genotyped and found to have either elevated or average risk based on a CAD IRS. Participants will be randomized into two equal groups: one group will receive their IRS result for coronary artery disease at baseline, and the other group will receive their ASCVD Pooled Cohorts Equation result at baseline and CAD IRS result approximately 3 years after enrollment. Subject data will be collected for 5 years from the time of enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Intervention | Experimental | Participants will receive their integrated risk score result for coronary artery disease. |
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| No Intervention: Control | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disclosure of integrate risk score for coronary artery disease | Genetic | Participants will receive their integrated risk score for coronary disease along with an optional genetic counseling visit to discuss the results. |
| Measure | Description | Time Frame |
|---|---|---|
| Does receiving an IRS report influence clinical decision making, including the provider's decision to treat with lipid lowering medication or order diagnostic testing? | Aggregating longitudinal clinical data will be collected to compare the incidence of lipid-lowering medication initiation and cardiac diagnostic testing between the intervention arm which received their integrated risk score and the control group. | 5 years |
| Does receiving an IRS report affect patient clinical measurements, including LDL-C levels? | Aggregating longitudinal clinical data will be collected to compare the clinical measurements between the intervention arm which received their integrated risk score and the control group. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Does the IRS identify those at elevated risk for CAD and future ASCVD events? | Aggregated longitudinal clinical data and patient survey data will be collected to compare patient clinical outcomes in those with a high CAD IRS. | 5 years |
| Does receiving an IRS report affect the incidence of CAD events? |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| University of Pennsylvania |
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Aggregated longitudinal clinical data will be collected to compare patient clinical outcomes in those with a CAD IRS reported at baseline and the control group. |
| 5 years |
| Does receiving an IRS report affect participant understanding of their individual CAD risk? | Patient survey data will be collected to assess their understanding of their CAD risk. | 5 years |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000096442 | Genetic Risk Score |
| D006331 | Heart Diseases |
| D003327 | Coronary Disease |
| D009203 | Myocardial Infarction |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020022 | Genetic Predisposition to Disease |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
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