Major Adverse Cardiovascular Events (MACE), Myocardial Injury After Non-cardiac Surgery, Urologic Cancer
Conditions
Keywords
Artificial Intelligence, Electrocardiography, Myocardial Injury After Non-cardiac Surgery, Major Adverse Cardiovascular Events, Perioperative Cardiovascular Risk, Urologic Cancer
Brief summary
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.
Detailed description
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.
Interventions
This is a prospective observational study. No interventions are administered. Participants are followed for the development of myocardial injury after major non-cardiac surgery.
Sponsors
Korea University Anam Hospital
The Catholic University of Korea
Keimyung University Dongsan Medical Center
Medical AI Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Myocardial Injury After Non-Cardiac Surgery (MINS) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with 30-Day Major Adverse Cardiovascular Events (MACE) | Within 30 days after surgery | Composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke occurring within 30 days after surgery. |
Countries
South Korea
Contacts
CONTACTDong Hyuck Cho, MD, PhD
CONTACTJong-Chan Youn, MD, PhD
PRINCIPAL_INVESTIGATORDong Hyuck Cho, MD, PhD
Korea University Anam Hospital
Outcome results
None listed