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临床试验/NCT07098468
NCT07098468已完成不适用

Evaluation of the Incidence and Risk Factors of Myocardial Injury After Noncardiac Surgery (MINS) in Patients Undergoing Knee and Hip Arthroplasty

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 323 人开始时间: 2025年8月3日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
323
试验地点
1
主要终点
Ischemia-related myocardial damage after noncardiac surgery

研究概览

简要总结

The aim of this study is to determine the incidence of myocardial injury after noncardiac surgery (MINS) in patients undergoing elective total knee or hip arthroplasty, and to identify the demographic, clinical, laboratory, and surgical risk factors that may contribute to its development.

详细描述

Cardiovascular complications that develop during the perioperative period stand out as a significant cause of morbidity and mortality in patients after surgery. Especially myocardial injury (MINS) occurring after non-cardiac surgeries often progresses without clinical symptoms and signs, and therefore its diagnosis can be missed. The early detection of this silent damage is of great importance for patient safety and treatment management. It is reported that 5% to 25% of patients after non-cardiac surgery have elevated cardiac troponin (cTn) levels, and most of these patients are asymptomatic. This situation suggests that many patients are exposed to undetected myocardial damage. In patients who have experienced myocardial infarction (MI) or myocardial injury, morbidity and mortality rates are high not only before surgery but also on the 30th day and even up to the 1st year. MINS is typically detected during the perioperative period through measurements of cardiac troponin I (cTnI) or cardiac troponin T (cTnT).

These proteins are the fundamental regulatory proteins of the myocardium and are sensitive and specific biomarkers for myocardial damage. Elevations in troponin levels should be identified within the first 30 days, but these elevations typically occur within the first 2 days of the postoperative period. When high-sensitivity troponin T (hs-cTnT) measurements are used, an increase of 5 ng/L or more over the previous value has been independently associated with 30-day mortality in a major international study. The aim of this study is to determine the incidence of myocardial injury after non-cardiac surgery (MINS) in patients undergoing elective total knee or hip arthroplasty and to identify the demographic, clinical, laboratory, and surgical risk factors that may contribute to it.

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

入选标准

  • Age over 45
  • Elective total knee or hip replacement

排除标准

  • Those undergoing cardiac surgery
  • History of acute MI (<30 days)
  • Chronic elevation of troponin

研究组 & 干预措施

Mins positivity

Patients with high sensitive troponin positivity after surgery

Mins Negative

Patients with negative high sensitive troponin after surgery

结局指标

主要结局

Ischemia-related myocardial damage after noncardiac surgery

时间窗: After surgery 30 days

Diagnostic Biochemical Criteria for MINS: Myocardial Injury after Non-Cardiac Surgery (MINS) is defined when at least one of the following high-sensitivity cardiac troponin T (hs-cTnT) criteria is met: A postoperative hs-cTnT level of at least 20 ng/L combined with a minimum absolute increase of 5 ng/L from the preoperative value, or An absolute postoperative hs-cTnT concentration of ≥ 65 ng/L, regardless of baseline values. These threshold values are used to detect subclinical myocardial injury due to ischemia that occurs after surgery, even in the absence of ischemic symptoms or electrocardiographic changes. In this study, patients meeting at least one of the above criteria within 30 days postoperatively will be classified as having MINS.

次要结局

  • Causes of myocardial damage due to ischemia following noncardiac surgery(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet sahap

Asist prof

Ankara City Hospital Bilkent

研究点 (1)

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