Artificial Intelligence-Enhanced ECG for Predicting Cardiac Magnetic Resonance-Defined Myocardial Injury in Acute Myocardial Infarction: An External Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 461
- 试验地点
- 1
- 主要终点
- Large myocardial infarct on CMR
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Duplicate AMI enrollment
- •Invalid ECG-CMR date linkage
- •No valid pre-PCI 12-lead ECG processable by both algorithms
研究组 & 干预措施
Consecutive AMI patients (STEMI or NSTEMI) undergoing PCI with a valid pre-PCI 12-lead ECG processab
结局指标
主要结局
Large myocardial infarct on CMR
时间窗: 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.
次要结局
- 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.)
研究者
Yongcheol Kim
Professor (Division of Cardiology)
Yonsei University