Prediction of Myocardial Injury After Non-Cardiac Surgery in Urologic Cancer Patients

N/ANot Yet RecruitingNCT07634666

Korea University Anam Hospital200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Myocardial Injury After Non-cardiac Surgery Urologic Cancer Major Adverse Cardiovascular Events (MACE)

Interventions

No intervention assignedOTHER

This is a prospective observational study. No interventions are administered. Participants are followed for the development of myocardial injury after major non-cardiac surgery.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Myocardial Injury After Non-Cardiac Surgery (MINS)

Myocardial injury after non-cardiac surgery (MINS) defined as 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).

Time frame: Intraoperative day and postoperative days 1-2 (within 3 days after surgery)

Secondary Outcomes

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.

Time frame: Within 30 days after surgery

Central Contacts

Dong Hyuck Cho, MD, PhD

CONTACT

+82-2-920-5448 why012@gmail.com

Jong-Chan Youn, MD, PhD

CONTACT

+82-2-2258-6145 jong.chan.youn@gmail.com

Data from ClinicalTrials.gov

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