Minimal Invasive Imaging of Coronary Artery Disease in Patients With Asymptomatic Myocardial Injury After Major Non-cardiac Surgery.
试验速览
- 阶段
- 不适用
- 发起方
- UMC Utrecht
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Coronary artery disease
研究概览
简要总结
This is a cross-sectional pilot study to assess coronary artery disease with minimal invasive techniques in patients with asymptomatic troponin elevation after noncardiac surgery. The primary objective is to quantify coronary artery disease, as determined by coronary CT and MR, as a cause of postoperative myocardial injury. The secondary objective is to correlate coronary calciumscore to postoperative levels of troponin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major noncardiac surgery with a planned minimal postoperative hospital stay of 2 days
- •Age > 59 years
- •Troponin_I elevation > 0.06 ng/ml in the first 3 post-operative days
- •No clinical symptoms of myocardial ischemia
排除标准
- •Perioperative troponin elevation due to other factors than coronary artery disease such as proven pulmonary embolism or sepsis
- •Perioperative ST-elevation myocardial infarction (STEMI)
- •Perioperative symptomatic angina with troponin elevation
- •Patients with a history or ECG-signs of myocardial infarction
- •Patients with pre-existent heart failure, left ventricular dysfunction, significant valvular disease or left ventricle hypertrophy
- •Patients with significant valvular disease or left ventricle hypertrophy determined postoperatively with echocardiography.
- •Contra-indication for CMR such as claustrophobia or metal prosthesis
- •Allergic reaction to CT-contrast or gadolinium
- •Renal dysfunction with GFR < 50 ml/min, as determined after the operation
- •Unstable hemodynamics or other conditions disabling transport to the Radiology department
- •Expected major discomfort or substantial increase in pain sensation by undergoing CCTA or CMR
- •Admission at the ICU
- •Poor prognosis due to other medical conditions e.g. malignancy
研究组 & 干预措施
1. TnI elevation
TnI 0.06-0.60ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging
干预措施: Minimal invasive cardiac imaging (Other)
2. TnI elevation
TnI 0.61-6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging
干预措施: Minimal invasive cardiac imaging (Other)
3. TnI elevation
TnI>6.00 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging
干预措施: Minimal invasive cardiac imaging (Other)
4. TnI elevation
TnI >6.00 ng/ml, ischemia on ECG and Hb<5.1. Intervention: minimal invasive cardiac imaging
干预措施: Minimal invasive cardiac imaging (Other)
5. TnI elevation
TnI >6.00 ng/ml, ischemia on ECG and Hb>5.0. Intervention: minimal invasive cardiac imaging
干预措施: Minimal invasive cardiac imaging (Other)
Control
TnI <0.06 ng/ml, no ischemia on ECG. Intervention: minimal invasive cardiac imaging
干预措施: Minimal invasive cardiac imaging (Other)
结局指标
主要结局
Coronary artery disease
时间窗: During hospital admission
Coronary artery disease with luminal narrowing \> 50 % in one or more major epicardial vessels by CCTA.
次要结局
- Coronary calcium score(During hospital admission)
- Extent of coronary artery atherosclerosis(During hospital admission)
- Minimal myocardial injury(During hospital admission)
研究者
Wilton A van Klei
W.A. van Klei, MD PhD
UMC Utrecht