Ruling Out Coronary Artery Disease and Myocardial Injury by BiOmarkers: Light'n Easy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- The presence of obstructive coronary artery stenosis defined as diameter > 50% on CCTA
研究概览
简要总结
A considerable proportion of patients with clinically suspected coronary artery disease (CAD) do not have angiographic signs of luminal narrowing caused by coronary atherosclerosis. In patients with suspected CAD, we will assess the ability of cardiovascular biomarkers to identify patients with (a) angiographically normal epicardial coronary vessels (b) absence of significant epicardial coronary stenosis, as assessed by coronary computed tomography angiography (CCTA). Patients will be stratified according to the presence or absence of dynamic changes of high sensitivity cardiac troponin T levels above the 99th percentile.
详细描述
This is an observational study of patients with suspected coronary artery disease referred to coronary computed tomography angiography (CCTA). The plan is to include 1000 patients prior to CCTA at two centers.
Blood samples for biomarker measurement will be obtained prior to the procedures. The diagnostic results of the imaging tests will be compared to the levels of circulating troponins. Patient will be followed for a minimum of 12 months and the incidence of cardiovascular death, all-cause mortality, acute coronary syndromes, revascularization, heart failure, stroke and cardiac arrhythmias requiring rehospitalization. Symptoms of angina pectoris according to the Canadian Cardiovascular Society grading of angina pectoris and symptoms of chronic heart failure according to the New York Heart Association classification of chronic heart failure will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting patient over the age of 18 referred to CCTA for suspected coronary artery disease
排除标准
- •Inability to provide informed consent.
- •Short life expectancy (<12 months) due to non-cardiovascular disease
结局指标
主要结局
The presence of obstructive coronary artery stenosis defined as diameter > 50% on CCTA
时间窗: 0 days (Cross-sectional)
Diagnostic end-point
次要结局
- The presence of non-obstructive coronary artery stenosis defined as diameter stenosis 30-50% on CCTA(0 days (Cross-sectional))
- Composite of cardiovascular death and hospitalization for heart failure or acute coronary syndrome(Follow-up until 2030)
- Incidence of cardiovascular death, hospitalization for myocardial infarction, unstable angina, revascularization, stroke, heart failure and cardiac arrhythmias.(Follow-up until 2030)
研究者
Torbjorn Omland
Professor
University Hospital, Akershus