Clinical Characteristics and Functional Outcomes of Postoperative Myocardial Injury: A Prospective Cohort Study - Troponin Elevation After Major Noncardiac Surgery 2
试验速览
- 阶段
- 不适用
- 发起方
- UMC Utrecht
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Disability
研究概览
简要总结
Major adverse cardiac events (MACE) are a leading cause of mortality in patients undergoing noncardiac surgery. Patients with perioperative myocardial injury (PMI), defined as either myocardial infarction and lower elevations in cardiac troponin, are also at substantially increased risk of additional cardiac and noncardiac complications. Accordingly, it is plausible to assume that PMI negatively affects quality of life in terms of disability. The aim of this study is to investigate and compare the independent prognostic effects of the different PMI phenotypes (myocardial infarction and non-infarct troponin elevations) and noncardiac complications on disability in patients undergoing elective noncardiac surgery.
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 all noncardiac surgical procedures requiring an expected hospital stay of at least 24 hours;
- •Elective surgery, defined as surgery that that has been preceded by a preoperative consultation at the anesthesia preoperative screening outpatient clinic.
排除标准
- •Patients unable to fully comply to study needs (e.g. legally incapable patients or patients unable to communicate in Dutch or English).
- •Patients with an American Society of Anesthesiologists (ASA) Physical status 5
结局指标
主要结局
Disability
时间窗: 6 months after surgery
Disability is expressed by the World Health Organization Disability Assessment Score 2.0 (WHODAS 2.0), which is based on difficulties experienced by the respondent in different functional domains including, cognition, mobility, self-care, getting along, life activities and participation during the previous 30 days. Disability is defined as a decrement in each functioning domain corresponding to score between 0% and 100%, in which no disability stands for a score of 0% and full disability represents a score of 100%, including death.
次要结局
- Major adverse cardiovascular event (MACE)(6 months after surgery)
- Length of hospital stay(1 week after surgery)
- All-cause mortality(6 months after surgery)
- Disability free survival(6 months after surgery)
- Noncardiac major adverse postoperative events (MAPE)(1 week after surgery)