Prospective Validation of DL Model for Postoperative MACC... | NCT07054502

Studies
Prospective Validation of DL Model for Postoperative MACCE Prediction

NCT07054502

Sponsor

Seoul National University Hospital

Status

Not yet recruiting

Last Update Posted

Jul 8, 2025Actual

Enrollment

7,000Estimated

Phase

Not provided

Conditions

Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2025Estimated

Primary Completion Date

Nov 30, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jun 27, 2025

First Submission Date that Met QC Criteria

Jun 27, 2025

First Posted Date

Jul 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2025

Last Update Posted Date

Jul 8, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyun-Kyu Yoon, Clinical Associate Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-cardiac surgical patients		Patient undergoing non-cardiac surgery under regional or general anesthesia

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Non-cardiac surgical patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hyun-Kyu Yoon, MD	Contact	82-2-2072-1146		hyunkyu18@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided