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The overall goal of this study is to develop a combined polygenic risk score (PRS) and metabolic risk score (MRS) and determine its impact on selecting community members for CCS. The trial component of this study will compare the use of these scores to motivate people to adhere to therapy, an ongoing challenge for clinicians, by providing feedback in a meaningful form to both the clinicians and the patients.
Patients undergoing a polygenic risk score (PRS), metabolic risk score (MRS) and coronary calcium score (CCS) will be randomized to receive PRS and CCS information and followed for the reduction of risk over 12 months. This information will provide information about how to motivate people to adhere to therapy, by providing feedback in a meaningful form to both the clinicians and the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRS score group | Experimental | Risk information provided on the basis of Polygenic Risk Score combined with the Pooled Cohort Equation |
|
| CCS score group | Active Comparator | Risk information provided on the basis of Coronary Calcium Score combined with the Pooled Cohort Equation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polygenic Risk Score | Diagnostic Test | Risk description to patient based on PRS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiovascular risk in each group | Change in cardiovascular risk (expressed as pooled cohort equation 10-year risk percentage) from baseline to follow-up | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence in each group | Proportion of lipid-lowering tablets taken | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas H Marwick, MD, PhD, MPH | Baker Heart and Diabetes Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baker Heart and Diabetes Institute | Melbourne | Victoria | 3004 | Australia |
Data sharing based available on application to the study PI
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Randomization to provision of PRS-based or CCS-based risk
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Outcomes assessor will receive baseline and 12 month risk based on Pooled Cohort Equation and photographic evidence of treatment adherence
| Coronary Calcium Score |
| Diagnostic Test |
Risk description to patient based on CCS |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |