Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTPolygenic Risk Score
Risk description to patient based on PRS
DIAGNOSTIC_TESTCoronary Calcium Score
Risk description to patient based on CCS
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor will receive baseline and 12 month risk based on Pooled Cohort Equation and photographic evidence of treatment adherence
Intervention model description
Randomization to provision of PRS-based or CCS-based risk
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Asymptomatic subjects age 40-70y 2. Statin naïve 3. TC ≤ 6.5 mmol/L and LDLC \<5 mmol/L, and 4. 5 year Australian risk ≥2%.
Exclusion criteria
1. Symptomatic coronary, cerebrovascular, or peripheral vascular disease 2. Intolerance of statins or currently on statins for any length of time 3. Pre-existing muscle disease (eg polymyositis, fibromyalgia) - this may be confused with myalgia from statins 4. Patients on drugs that increase the risk of myopathy/rhabdomyolysis such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV/hepatitis C protease inhibitors) 5. Atrial fibrillation (interferes with CTCA) 6. Chronic kidney disease on haemodialysis (because of vascular calcification) or GFR \<50ml/min per 1.73m2 using the Modification of Diet in Renal Disease (MDRD) formula 7. Inability to provide informed consent 8. Major systemic illness eg. malignancy; rheumatoid arthritis 9. Women of child bearing potential (due to performance of CT) 10. Poorly controlled hypertension: SBP\> 200 and or DBP \> 100 11. Severe psychiatric disorder (eg bipolar depression; psychosis) 12. Patients eligible for treatment based on current Australian guidelines (5 year risk \>15%) 13. Patients eligible for treatment based on current PBS thresholds TC \>7.5 mmol/l and other criteria (see below).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiovascular risk in each group | 12 months | Change in cardiovascular risk (expressed as pooled cohort equation 10-year risk percentage) from baseline to follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence in each group | 12 months | Proportion of lipid-lowering tablets taken |
Countries
Australia
Outcome results
None listed