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临床试验/NCT04537741
NCT04537741进行中(未招募)不适用

Coronary CT Angiography in Non ST-elevation Myocardial Infarction (NSTEMI) - a Way to Reduce Unnecessary Invasive Investigations

St. Olavs Hospital8 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年10月24日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: Coronary CT angiography (Procedure)

NSTEMI scheduled for angiography

Experimental

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

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (8)

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