Coronary Artery Disease
Conditions
Brief summary
This study will investigate the role of polygenic risk scores (PRS) in preventive health.
Detailed description
This study will investigate the role of polygenic risk scores (PRS) in preventive health. Specifically, the purpose of this study is to determine whether knowledge of the degree of coronary artery disease (CAD) genetic risk, as measured and conveyed by a PRS, influences patient and physician decision-making during short-term (6 month) and long-term (2 year) follow-up. The initial findings of this study will be used to plan an expanded second phase study with the purpose of prospectively validating that these decision-making changes lead to improvements in clinical outcomes.
Interventions
None listed
Sponsors
Illumina, Inc.
Quest Diagnostics-Nichols Insitute
Scripps Translational Science Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 45 ≥ Age \< 65 * ASCVD Risk Score \> 7.5% as defined by the standard pooled cohort equation * Access to and ability to use a smartphone
Exclusion criteria
* Prior diagnosis of coronary disease as defined by prior myocardial infarction (STEMI or NSTEMI), or revascularization (stent or coronary artery bypass grafting) * Cerebrovascular disease with history of ischemic stroke, TIA, carotid endarterectomy, carotid artery stenting * Peripheral arterial disease with history of claudication, revascularization (stents or bypass) * Current and active high-intensity statin prescription (rosuvastatin 20 mg, rosuvastatin 40 mg, atorvastatin 40 mg and atorvastatin 80 mg) * Anti-PCSK9 therapy * Lipid apheresis therapy * Currently enrolled in a clinical trial for lipid lowering therapy * Known statin intolerance to 2 or more statins in the past
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Statin or other lipid lowering therapy initiation or intensification by EHR entry | 6 months post enrollment | New or intensified prescriptions for statins or other LDL lowering therapy. Binary outcome measured at 6-months post-enrollment by survey-based self-report and EHR analysis - encoded as 0 if no new or intensified prescription relative to medication status at baseline, and 1 if a new or intensified prescription is entered in the EHR relative to medication status at baseline. A prescription for statins or other LDL lowering therapy is considered new if an EHR entry for a statin, PCSK9i, or ezitimibe is present at follow-up and no equivalent EHR entry exists for up to 1-year prior to enrollment. A statin prescription is considered intensified if an active statin prescription is present in the EHR at enrollment and an active statin prescription of a higher intensity tiers (high-, moderate-, and low-intensity) as described in the 2013 ACC/AHA Guidelines on the Treatment of Blood Cholesterol is present at follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Statin or other lipid lowering therapy persistence by EHR entry | 2 years post enrollment | Statin or other lipid lowering therapy prescription renewal. Binary outcome measured at 2-years post-enrollment by EHR analysis. Statin persistence is defined as prescription renewal within 60 days of the end of the duration of an index statin prescription made after study enrollment |
| Statin or other lipid lowering therapy adherence by EHR entry | 2 years post enrollment | Statin or other lipid lowering therapy prescription possession. Binary outcome measured at 2-years post-enrollment by EHR entry. Statin adherence is defined as prescription coverage of no less than 80% of the days between the index statin prescription and the end of the 2-year follow-up period |
| Adequate LDL-C lowering - comparison of baseline and follow-up measures by lab test | 6 months and 2 years post enrollment | Adequate LDL-C lowering. Adequate LDL-C lowering is defined as 30% or more reduction from baseline study measured LDL-C |
| Lifestyle changes by survey | 6 months post enrollment | Adoption of Healthy Lifestyle. Binary outcomes derived from baseline and 6-months post-enrollment by survey-based self-report. |
| Physician Utility by survey | 6 months and 1 year | Physician confidence, perceived utility, and actions attributable to genomic testing. |
Contacts
Primary ContactAli Torkamani, PhD
Outcome results
None listed