About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients aged 60 years or older scheduled for major non-cardiac surgery under general anesthesia due to urologic malignancy (e.g., radical prostatectomy, radical nephrectomy, partial nephrectomy) will be prospectively enrolled from participating centers. All eligible patients who provide informed consent and meet inclusion criteria will be followed for perioperative myocardial injury and 30-day cardiovascular outcomes.
Trial design
Cohort
Prospective
Treatments tested in this trial
No intervention assigned
Other interventionThis is a prospective observational study. No interventions are administered. Participants are followed for the development of myocardial injury after major non-cardiac surgery.
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with Myocardial Injury After Non-Cardiac Surgery (MINS)
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)
Secondary outcomes
Number of Participants with 30-Day Major Adverse Cardiovascular Events (MACE)
Composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke occurring within 30 days after surgery.
Sponsors and contacts
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Korea University Anam Hospital
Lead sponsor
The Catholic University of Korea
Collaborator
Keimyung University Dongsan Medical Center
Collaborator
Medical AI Co., Ltd
Collaborator