Artificial Intelligence-Powered Electrocardiogram Detecting Culprit Vessel Blood Flow Abnormality in Acute Coronary Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 9
- 主要终点
- Diagnostic Accuracy of the AI-ECG TIMI AI Model
研究概览
简要总结
AI ECG TIMI is an investigator-initiated, international, and multicenter registry of acute coronary syndrome patients aimed to identify electrocardiographic findings detected by an AI model predicting coronary blood flow alteration. The aim of the study is to identify electrocardiographic findings detected by an automated artificial intelligence (AI) model that can predict coronary blood flow alteration as assessed by the TIMI grade flow at the very moment of the invasive coronary angiography in patients with acute coronary syndromes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute coronary syndromes undergoing invasive coronary angiography as clinically indicated.
- •Availability of a standard 12-lead ECG performed at invasive coronary angiogram before percutaneous coronary intervention (maximum within 15 min before vascular access).
- •Age ≥18 years.
排除标准
- •Individuals presenting for a non-emergent (elective) cardiac catheterization.
- •Individuals presenting with chronic coronary syndrome (CCS) or stable angina symptoms.
- •Individuals without symptoms suspicious for acute coronary syndromes.
- •Individuals with contraindications for cardiac catheterization.
结局指标
主要结局
Diagnostic Accuracy of the AI-ECG TIMI AI Model
时间窗: Index hospitalization (assessed up to 5 days)
The primary endpoint is the AI-ECG TIMI model's ability to identify patients with actively occluded (TIMI 0-1) at the time of invasive coronary angiography using only single-standard 12-lead ECGs assessed by accuracy, sensitivity, specificity, positive, negative predictive values and F1 scores.
次要结局
- Subgroup Performance(Index hospitalization (assessed up to 5 days))
- ECG prediction of mechanical reperfusion(Index hospitalization (assessed up to 5 days))
- Assessment of expert ECG interpretation blinded to all clinical information(Index hospitalization (assessed up to 5 days))
- STEMI-equivalent ECG patterns(Index hospitalization (assessed up to 5 days))
- Correlate established definitions of occlusion myocardial infarction (OMI) to myocardial perfusion status(Index hospitalization (assessed up to 5 days))
- Subgroup analysis of NSTEMI-OMI patients(Index hospitalization (assessed up to 5 days))