Prospective Validation of DL Model for Postoperative MACCE Prediction

NCT07054502 | Not Yet Recruiting DMC

• 1 other identifier: 2503-210-1630
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to prospectively validate a deep learning model developed using retrospective data to predict major adverse cardiac and cerebrovascular events (MACCE) occurring within 30 days after non-cardiac surgery. The validation will be performed using prospectively collected data from patients undergoing non-cardiac surgery under general or regional anesthesia.

Conditions

Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

Keywords

Deep learning; Non-cardiac surgery; Electrocardiogram; Multimodal; MACCE

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular and cerebrovascular events (MACCE)

  Occurrence of MACCE within 30 days after surgery (composite outcome including myocardial infarction, stroke, coronary revascularization, heart failure, and death)

  within 30 days after surgery

Study Arms (1)

Non-cardiac surgical patients

Patient undergoing non-cardiac surgery under regional or general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-cardiac surgical patients

You may qualify if:

• Adults aged 18 or older undergoing non-cardiac surgery under general or regional anesthesia at Seoul National University Hospital

You may not qualify if:

• Reoperation within 30 days after initial surgery
• Organ procurement or pregnancy-related procedures
• Ambulatory-based surgery
• Preoperative tracheal intubation before entering the operating room
• Surgeries performed outside the operating room

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Central Study Contacts

Hyun-Kyu Yoon, MD

CONTACT

82-2-2072-1146; hyunkyu18@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: July 10, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)