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Completed

NCT Number: NCT07751809

AI-ECG for Predicting CMR-Defined Myocardial Injury in Acute Myocardial Infarction

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).

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Key information

Conditions

Acute Myocardial Infarction (AMI)

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yongin Severance Hospital, Yonsei University College of Medicine

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

About this study

Consecutive patients with acute myocardial infarction undergoing PCI and subsequent CMR at Yongin Severance Hospital (April 2020-June 2025) were identified. Two approved AI-ECG algorithms were applied to the first 12-lead ECG obtained at emergency-department presentation (pre-PCI). CMR was performed a median of 3 days (IQR 2-5) after PCI. The diagnostic performance of each AI-ECG score for the CMR-defined endpoints was assessed by the area under the ROC curve (AUC), with sensitivity, specificity, and predictive values at prespecified and cohort-optimal (Youden) cutoffs, and by logistic regression. The final analysis cohort comprised 461 patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Large myocardial infarct on CMR

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

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

Secondary outcomes

  1. CMR-defined LV systolic dysfunction

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

    CMR-derived left ventricular ejection fraction (LVEF) ≤40%.

  2. Microvascular obstruction (MVO)

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

    Presence of microvascular obstruction on CMR.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Medical AI

Registry information

Official study title

Artificial Intelligence-Enhanced ECG for Predicting Cardiac Magnetic Resonance-Defined Myocardial Injury in Acute Myocardial Infarction: An External Validation Study

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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