Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring in at Risk Patients: Comparison With Coronary Computed Tomography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,059
- 试验地点
- 2
- 主要终点
- Change in cardiovascular risk in each group
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will receive baseline and 12 month risk based on Pooled Cohort Equation and photographic evidence of treatment adherence
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic subjects age 40-70y
- •Statin naïve
- •TC ≤ 6.5 mmol/L and LDLC <5 mmol/L, and
- •5 year Australian risk ≥2%.
排除标准
- •Symptomatic coronary, cerebrovascular, or peripheral vascular disease
- •Intolerance of statins or currently on statins for any length of time
- •Pre-existing muscle disease (eg polymyositis, fibromyalgia) - this may be confused with myalgia from statins
- •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)
- •Atrial fibrillation (interferes with CTCA)
- •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
- •Inability to provide informed consent
- •Major systemic illness eg. malignancy; rheumatoid arthritis
- •Women of child bearing potential (due to performance of CT)
- •Poorly controlled hypertension: SBP> 200 and or DBP > 100
- •Severe psychiatric disorder (eg bipolar depression; psychosis)
- •Patients eligible for treatment based on current Australian guidelines (5 year risk >15%)
- •Patients eligible for treatment based on current PBS thresholds TC >7.5 mmol/l and other criteria (see below).
结局指标
主要结局
Change in cardiovascular risk in each group
时间窗: 12 months
Change in cardiovascular risk (expressed as pooled cohort equation 10-year risk percentage) from baseline to follow-up
次要结局
- Medication adherence in each group(12 months)