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临床试验/NCT07179029
NCT07179029招募中不适用

Anesthesia Induced Myocardial Injury in Non-cardiac Surgery (AIMY)

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
1
主要终点
Troponin

研究概览

简要总结

Myocardial injury during non-cardiac surgery (PMI) affects up to 16% of high-risk patients and represents a significant burden on healthcare systems. An acute myocardial infarction is defined by a dynamic increase in cardiac troponin (cTn) above the 99th percentile and is accompanied by clinical signs of myocardial ischemia. Myocardial injury, on the other hand, is characterized by an increase in cardiac troponin, but without meeting the diagnostic criteria for myocardial infarction. In the perioperative interval, however, it is irrelevant whether a myocardial infarction according to the universal definition or merely an increase in troponin is present, as there is no difference in mortality between the two patient groups. The comprehensive study by Botto et al. provides valuable insights into the severity of MINS and found that 8.0% of patients met the diagnostic criteria. An important finding of this study is that the majority of MINS cases (87.1%) occurred within the first two days after surgery, highlighting the immediate risk of the condition (Botto et al., 2014).

We would like to emphasize the necessity of our prospective, multicenter observational study by highlighting anesthesia-dependent variables such as hemodynamics, type of medication, their potential role, and surgical aspects such as duration of surgery, which represent risk factors for MINS. Identifying and understanding modifiable and non-modifiable risk factors is essential for targeted preoperative intervention. Understanding these factors is crucial for subsequent interventional studies and can also provide criteria for increased monitoring of high-risk patients, as suggested in the current guidelines.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective or emergency non-cardiac surgery
  • Cardiovascular risk: At least two of the following: Age >60 years, hypertension, diabetes mellitus, coronary heart disease, peripheral arterial occlusive disease, cerebrovascular disease, chronic renal insufficiency, chronic heart failure, chronic obstructive pulmonary disease, active smoking
  • Age criteria: Adults aged 40-80 years.
  • ASA status: ASA classification II-IV.
  • Written consent after prior explanation

排除标准

  • o Patients unable to give consent: intubated and sedated patients
  • Types of surgery: cardiac surgery, including coronary artery bypass grafting, heart valve repair or replacement, and heart transplantation; obstetric procedures, including cesarean section; minor surgical procedures that do not require general or regional anesthesia (e.g., minor dermatological or ophthalmological procedures)
  • Cardiovascular risk: patients without at least two of the following risk factors: age <40 or >80, no history of hypertension, diabetes, coronary artery disease, peripheral arterial disease, cerebrovascular disease, chronic renal failure, chronic heart failure, chronic obstructive pulmonary disease, and non-smoker status
  • Age criteria: Patients under 40 or over 80 years of age
  • ASA status: ASA classification of I.

结局指标

主要结局

Troponin

时间窗: 1-5 days

Development of Troponin after non-cardiac surgery

incidence of PMI

时间窗: 1-5 days

incidence of PMI after non-cardiac surgery

次要结局

  • Mortality(1-30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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