Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Coronary heart disease death or non-fatal myocardial infarction
研究概览
简要总结
It is hypothesised that, in individuals being considered for cardiovascular preventative therapy, computed tomography coronary angiography guided management will reduce the future risk of coronary heart disease death or non-fatal myocardial infarction compared to management guided by the current standard of care, a cardiovascular risk score.
详细描述
Prevention of cardiovascular disease is currently guided by probabilistic risk scores that both over and under treat individuals, commit most middle-aged people to pharmacotherapy, and have little evidence base. It has been demonstrated that use of computed tomography coronary angiography (CTCA) is associated with changes in the diagnosis and treatment of patients presenting with stable chest pain, and that this leads to a marked reduction in the future risk of myocardial infarction. Importantly, the proportionate reduction in coronary events was most marked in those with non-anginal chest pain irrespective of their cardiovascular risk score which again demonstrated poor discrimination. The research team propose a randomised controlled trial of at least 6,000 middle-aged individuals at risk of cardiovascular disease that will compare these two strategies of targeting preventative therapies: a probabilistic cardiovascular risk score, and screening with CTCA. This trial will determine if CTCA guided management will be associated with better targeted intervention, prevent over medicating the general population, and result in fewer future coronary heart disease events than the current standard of care using a cardiovascular risk score.
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)
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
- 否
入选标准
- •≥40 and ≤70 years of age
- •Resident in Scotland and have a Community Health Index (CHI) number
- •One or more of the following risk factors:
- •>60 years of age
- •Current or recent (within 12 months) smoker
- •Clinical diagnosis of hypertension
- •Known hypercholesterolaemia or total cholesterol >6.0 mmol/L or receiving statin therapy
- •Diabetes mellitus
- •Rheumatoid arthritis
- •Systemic lupus erythematosus (SLE)
- •Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease below 60 years)
- •Chronic kidney disease stage 3 (estimate glomerular filtration rate 30-59 mL/min/1.73 m2).
排除标准
- •Inability to undergo CTCA
- •Known coronary heart disease or other major atherosclerotic cardiovascular disease
- •Prior invasive or non-invasive coronary angiography within the last 5 years
- •Chronic kidney disease stage ≥4 (estimate glomerular filtration rate <30 mL/min/1.73 m2)
- •Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy
- •Intolerance of all statins
- •Statin therapy for >2 years.
- •Previous coronary artery imaging completed specifically for cardiovascular risk assessment with a result of >10 AU.
研究组 & 干预措施
Computed tomography coronary angiography
干预措施: Computed tomography coronary angiography (Diagnostic Test)
Assign Score only
干预措施: ASSIGN Score (Other)
结局指标
主要结局
Coronary heart disease death or non-fatal myocardial infarction
时间窗: 5 years
The primary research objective of the trial is to determine whether, in individuals with risk for cardiovascular disease, coronary heart disease screening with CTCA is associated with a reduction in the rate of coronary heart disease death or non-fatal myocardial infarction when compared to a probabilistic cardiovascular risk score approach.
次要结局
- Cholesterol(5 Years)
- Quality of Life (EQ-5D-5L)(2 Years)
- Cardiovascular Events(5 Years)
- Cardiovascular Procedures(5 Years)
- Prescription(5 Years)
- Lifestyle Modification(2 Years)
- Health Economics(2 Years)
- Death(5 Years)
- Disadvantages of CTCA- Radiation(5 Years)
- Disadvantages of CTCA- incidental findings(5 Years)