Prediction of Myocardial Injury After Major Non-Cardiac Surgery in Patients With Urologic Cancer: A Prospective Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of Participants with Myocardial Injury After Non-Cardiac Surgery (MINS)
研究概览
简要总结
This prospective multicenter observational study aims to evaluate the predictive value of artificial intelligence-based analysis of preoperative 12-lead electrocardiography for myocardial injury after non-cardiac surgery (MINS) and major adverse cardiovascular events (MACE) within 30 days after surgery in patients undergoing non-cardiac surgery for urologic cancer.
详细描述
Myocardial injury after non-cardiac surgery (MINS) is associated with increased postoperative morbidity and mortality. Patients with urologic cancer undergoing major non-cardiac surgery may be at increased risk for perioperative cardiovascular complications. Early identification of patients at high risk for postoperative myocardial injury and adverse cardiovascular events may improve perioperative risk stratification and clinical management.
This prospective multicenter observational study aims to evaluate the predictive value of artificial intelligence-based analysis of preoperative 12-lead electrocardiography for postoperative myocardial injury after non-cardiac surgery (MINS) and major adverse cardiovascular events (MACE) within 30 days after surgery in patients undergoing non-cardiac surgery for urologic cancer.
Clinical characteristics, perioperative variables, electrocardiographic data, laboratory findings, and postoperative outcomes will be prospectively collected and analyzed to identify predictors of postoperative cardiovascular complications.
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
- •Age ≥ 60 years
- •Patients scheduled for major non-cardiac surgery under general anesthesia due to urologic cancer (e.g., radical prostatectomy, radical nephrectomy, partial nephrectomy)
- •Patients who undergo preoperative standard 12-lead electrocardiography
- •Patients classified as having intermediate or higher surgical risk
- •Patients who can be followed for at least 30 days postoperatively
- •Patients who voluntarily provide written informed consent to participate in this study
排除标准
- •History of major adverse cardiovascular events (MACE) within 6 months prior to surgery
- •Inability to obtain essential clinical information required for study participation and follow-up
- •Patients who are not hospitalized after surgery
- •Individuals deemed inappropriate for participation in the study by the investigator due to legal or psychiatric reasons
研究组 & 干预措施
Urologic cancer patients undergoing major non-cardiac surgery
Patients with urologic malignancy scheduled for major non-cardiac surgery will be prospectively enrolled and observed for perioperative myocardial injury and related outcomes.
干预措施: No intervention assigned (Other)
结局指标
主要结局
Number of Participants with Myocardial Injury After Non-Cardiac Surgery (MINS)
时间窗: Intraoperative day and postoperative days 1-2 (within 3 days after surgery)
Myocardial injury after non-cardiac surgery (MINS), defined as an elevation of fourth-generation cardiac troponin T measured on the day of surgery, postoperative day 1, and postoperative day 2 (within 3 days after surgery)
次要结局
- Number of Participants with 30-Day Major Adverse Cardiovascular Events (MACE)(Within 30 days after surgery)
研究者
Cho, Dong Hyuck
Associate Professor
Korea University Anam Hospital