Coronary CT Angiography in Non ST-elevation Myocardial Infarction (NSTEMI) - a Way to Reduce Unnecessary Invasive Investigations
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- The number of patients with coronary artery disease in need for revascularization as defined by invasive coronary angiography including invasive iFR/FFR
研究概览
简要总结
Non ST-elevation myocardial infarction (NSTEMI) represents 70-75% of all myocardial infarctions. Current guidelines recommend invasive angiography and this patient group represents a major burden on the invasive catheterization laboratories and the health care system.
The coronary pathology found in NSTEMI-patients varies substantially, ranging from structurally normal vessels, non-obstructive atherosclerosis to severe multivessel disease. 30-40 % of patients with NSTEMI undergoing invasive coronary angiography do not undergo revascularization. If these patients could be identified by a non-invasive method like coronary CT angiography (CCTA), an invasive procedure with the potential risk for complications could be avoided. Furthermore, less patients would need transfer to an invasive center. Both for patients and for health care costs this would be of major benefit.
The quality of CCTA images has improved during the years, and radiation dose has decreased. Due to technological development it is now possible to perform high quality coronary CCTA with a very low radiation dose (1-1.5 mSv) compared to a radiation dose of 3-4 mSv for invasive coronary angiography.
The overall aim of the project is to define a subpopulation of NSTEMI patients that preferably should undergo CCTA as the first step in imaging of the coronary arteries and thus potentially be saved from an unnecessary invasive investigation. This would result in less patient discomfort, less patient risk and reduced health care costs. Patients with a clinical indication for invasive angiography according to current guidelines will undergo CCTA prior to the invasive investigation. The ability of CCTA to identify those with no need for revascularization will be assessed using invasive angiography as the gold standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
CCTA will be analysed at a core lab with no information of the results from invasive angiography or whether coronary revascularization was performed or not.
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admitted to a local hospital with NSTEMI type 1 or type 2 based on clinical criteria
- •indication for invasive coronary angiography according to current guidelines
排除标准
- •indication for immediate (< 2 hours) invasive strategy according to guidelines
- •GRACE score > 140
- •not willing to provide written informed consent
- •previous coronary revascularization
- •estimated glomerular filtration rate < 30 mL/min/1,73m2
- •allergic reactions to contrast agents impeding for safe examinations
- •> 2 hypokinetic segments on echocardiography
研究组 & 干预措施
NSTEMI scheduled for angiography
干预措施: Coronary CT angiography (Procedure)
NSTEMI scheduled for angiography
干预措施: Invasive coronary angiography (Procedure)
结局指标
主要结局
The number of patients with coronary artery disease in need for revascularization as defined by invasive coronary angiography including invasive iFR/FFR
时间窗: 1 month
For the primary endpoint analysis will be performed on patient level
次要结局
未报告次要终点
