Direct Evaluation of Postoperative Myocardial Injury Using Coronary Computed Tomography Angiography After Non-Cardiac Surgery
试验速览
- 阶段
- 不适用
- 发起方
- UMC Utrecht
- 入组人数
- 354
- 主要终点
- Pulmonary Embolism
研究概览
简要总结
This is a prospective study in patients who undergo routine postoperative troponin assessment after major (semi-)elective noncardiac surgery. Two groups are created based on postoperative troponin levels: Postoperative myocardial injury (PMI) group with troponin I levels ≥ 60 ng/L and a control group with troponin levels < 60ng/L. The primary aim of this study is to assess the association of PMI with pulmonary embolism. Additionally, the association between PMI and obstructive CAD will be investigated.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 60 years old
- •Major noncardiac surgery, defined as non-cardiac surgical procedures requiring hospital admittance > 24 hours
- •Semi-elective surgery, defined as surgery that that has been preceded by a preoperative evaluation.
- •≥ 1 troponin assessment in the first 3 postoperative days as a part of the routine 'postoperative troponin assessment' protocol.
- •For patients who undergo surgery more than once, the first surgery will be included in the analysis. Reoperations will not be included.
排除标准
- •Typical anginal complaints
- •Acute ST-elevation myocardial infarction (STEMI) or new left bundle branch block (LBBB) on ECG
- •Patients unable to fully comply to study needs (e.g. incompetent patients or patients unable to communicate in Dutch or English)
- •Severe claustrophobia.
- •Patients who have a life expectancy of less than three months.
- •Patients who are too ill to undergo a CCTA or Ventilation/Perfusion (V/Q) scan.
结局指标
主要结局
Pulmonary Embolism
时间窗: 1 week
Pulmonary embolism (PE) on either Coronary Computed Tomography Angiography (CCTA) or Ventilation/Perfusion (V/Q) scan. PE on CCTA is defined as a sharply delineated pulmonary artery filling defect in at least two consecutive image sections of the CCTA, either located centrally within the vessel or with acute angles at its interface with the vessel wall. PE on V/Q scan is defined as at least one segmental or two subsegmental perfusion defects without corresponding abnormality on chest X-ray.
次要结局
- Obstructive coronary artery disease(1 week)
- 30-day all-cause mortality(30-day)
- major therapeutic changes(1 week)
- Obstructive main stem or proximal left anterior descending (LAD) stenosis(1 week)
- 30-day MACE(30 days)
- major diagnostic changes(1 week)
- bleeding(1 year after surgery)