Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury : the TROPUTILE Score. A Non-interventional Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- Postoperative MINS incidence
研究概览
简要总结
Myocardial injury after noncardiac surgery (MINS) is common, silent, and strongly associated with morbi-mortality.
There are some evidences in the littérature showing that troponin elevation pre and/or postoperatively and surgical Apgar score are strongly and independently associated with postoperative morbi-mortality.
In this cohort study of orthopedic surgery patients (> 50years), the aim is to determine MINS incidence and to assess wich peri-operative factors are associated with the occurrence of MINS. The final objective is to create a score to better identified the patients with a MINS and a poor outcome.
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
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 50 years
- •orthopedic surgery (hip, knee, spine)
- •written consent
排除标准
- •no troponin measurement prior surgery
- •acute coronary syndrome
- •pulmonary embolism
- •refusing to participate
- •guardianship
结局指标
主要结局
Postoperative MINS incidence
时间窗: 3 days after surgery
Troponin elevation \> 5ng/l compared to previous measurement OR troponin elevation \> 65 ng/l
次要结局
- Mortality rate(3 months)
- Number of Participants with myocardial infarction(3 months)
- Number of Participants with stroke(3 months)
- Number of Participants with an episode of acute pulmonary oedema(3 months)
- Number of Participants with coronary angioplasty(3 months)
- Number of Participants with transient stroke(3 months)
- Revised Cardiac Risk Index for Pre-Operative Risk (Lee score)(Inclusion)
- Metabolic Equivalent of Task (MET)(Inclusion)
- Number of Participants with cardiac arrest(3 months)