NCT07751809

Brief Summary

This retrospective, single-center external validation study evaluates whether two commercially approved artificial intelligence-enhanced electrocardiography (AI-ECG) algorithms (AiTiA LVSD and AiTiA MI; Medical AI Co., Ltd.), applied to a single pre-percutaneous coronary intervention (PCI) 12-lead ECG, predict cardiac magnetic resonance (CMR)-defined myocardial injury in patients with acute myocardial infarction (AMI). The primary endpoint is a large infarct (late gadolinium enhancement \>17.9% of left ventricular mass); secondary endpoints are CMR left ventricular ejection fraction (LVEF) ≤40% and microvascular obstruction (MVO).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
461

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

5.2 years

First QC Date

August 3, 2026

Last Update Submit

August 3, 2026

Conditions

Acute Myocardial Infarction (AMI)

Keywords

Artificial IntelligenceElectrocardiographycardiac magnetic resonanceAcute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Large myocardial infarct on CMR

    : Late gadolinium enhancement (LGE) \>17.9% of left ventricular mass, assessed on CMR. Discrimination of the pre-PCI AI-ECG score reported as AUC.

    CMR performed a median of 3 days (IQR 2-5) after PCI, during the index hospitalization.

Secondary Outcomes (2)

  • CMR-defined LV systolic dysfunction

    CMR performed a median of 3 days (IQR 2-5) after PCI.

  • Microvascular obstruction (MVO)

    CMR performed a median of 3 days (IQR 2-5) after PCI.

Study Arms (1)

Consecutive AMI patients (STEMI or NSTEMI) undergoing PCI with a valid pre-PCI 12-lead ECG processab

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive AMI patients undergoing PCI and post-PCI CMR, both algorithms were applied to the pre-PCI ECG

You may qualify if:

  • Acute myocardial infarction (STEMI or NSTEMI) undergoing PCI
  • Subsequent cardiac magnetic resonance imaging performed
  • Valid pre-PCI 12-lead ECG processable by both AI-ECG algorithms

You may not qualify if:

  • Duplicate AMI enrollment
  • Invalid ECG-CMR date linkage
  • No valid pre-PCI 12-lead ECG processable by both algorithms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongin Severance Hospital, Yonsei University College of Medicine

Yongin-si, Gyeonggi-do, 16995, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (Division of Cardiology)

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 7, 2026

Study Start

April 1, 2020

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

August 7, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be made available. The study analyzed retrospectively collected, de-identified data under an IRB-approved protocol with a consent waiver; the governing data-use terms do not permit sharing of individual participant data. Aggregate results are reported in the associated publication, and reasonable inquiries may be directed to the principal investigator.

Locations

KR(1)