Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT04604353
- Lead Sponsor
- Baker Heart and Diabetes Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1059
Inclusion Criteria:<br><br> 1. Asymptomatic subjects age 40-70y<br><br> 2. Statin naïve<br><br> 3. TC = 6.5 mmol/L and LDLC <5 mmol/L, and<br><br> 4. 5 year Australian risk =2%.<br><br>Exclusion Criteria:<br><br> 1. Symptomatic coronary, cerebrovascular, or peripheral vascular disease<br><br> 2. Intolerance of statins or currently on statins for any length of time<br><br> 3. Pre-existing muscle disease (eg polymyositis, fibromyalgia) - this may be confused<br> with myalgia from statins<br><br> 4. Patients on drugs that increase the risk of myopathy/rhabdomyolysis such as<br> cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and<br> HIV/hepatitis C protease inhibitors)<br><br> 5. Atrial fibrillation (interferes with CTCA)<br><br> 6. Chronic kidney disease on haemodialysis (because of vascular calcification) or GFR<br> <50ml/min per 1.73m2 using the Modification of Diet in Renal Disease (MDRD) formula<br><br> 7. Inability to provide informed consent<br><br> 8. Major systemic illness eg. malignancy; rheumatoid arthritis<br><br> 9. Women of child bearing potential (due to performance of CT)<br><br> 10. Poorly controlled hypertension: SBP> 200 and or DBP > 100<br><br> 11. Severe psychiatric disorder (eg bipolar depression; psychosis)<br><br> 12. Patients eligible for treatment based on current Australian guidelines (5 year risk<br> >15%)<br><br> 13. Patients eligible for treatment based on current PBS thresholds TC >7.5 mmol/l and<br> other criteria (see below).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in cardiovascular risk in each group
- Secondary Outcome Measures
Name Time Method Medication adherence in each group