LESTONNAC Study: Observed ST Elevation Does Not Require Acute Cardiac Necrosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 420
- 试验地点
- 7
- 主要终点
- Clinical validation of a screening model assisted by AI
研究概览
简要总结
Patients with chest pain and persistent ST segment elevation (STE) may not have acute coronary occlusions or serum troponin curves suggestive of acute necrosis. Our objective is the validation and cost-effectiveness analysis of a diagnostic model assisted by artificial intelligence (AI). Our hypothesis is that an AI analysis of the surface electrocardiogram allows a better distinction of patients with STE due to acute myocardial ischemia, from those with another etiology. This is a prospective multicenter study with two groups of patients with STE: I) coronary arteries without significant lesions and without serum troponin curve suggestive of acute necrosis, II) myocardial infarction with acute coronary occlusion. A manual centralized electrocardiographic analysis and another by AI algorithms will be performed.
详细描述
This is a prospective multicenter study promoted by the Ischemic Heart Disease and Acute Cardiovascular Care Section of the Spanish Society of Cardiology. Following institutional ethical approval, the surface ECG prior to the activation of the Infarction Code, and the ECGs before and after (up to a maximum of 20) the Infarction Code along with other clinical data will be collected across the different enrolled hospitals. Sites will securely transfer the data to a centralized repository for processing. Willem AI platform will automatically analyze the ECGs in parallel to an experienced observer. The results of the study will provide new information for the improvement in the stratification of patients with ST segment elevation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years.
- •Chest pain or symptoms suggestive of myocardial ischemia.
- •STE at point J in the12-lead electrocardiogram prior to activation of the infarction code in two contiguous leads ≥0.1 mV, in V2 and V3 ≥0.2 mV.
- •Signature of informed consent.
排除标准
- •Left bundle branch block.
- •Acute cardiac necrosis in the absence of significant epicardial coronary artery stenosis >70% (vasospasm, takotsubo stress cardiomyopathy, myocarditis, coronary artery dissection, acute myocardial infarction without obstructive coronary lesions - MINOCA).
- •STE≤0.1 mV with pathologic Q wave suggestive of previous chronic infarction.
- •Severe anemia (hemoglobin <8.0 g/dl).
结局指标
主要结局
Clinical validation of a screening model assisted by AI
时间窗: 6 months after the last enrolled patient
The detection performance of acute myocardial ischemia will be evaluated for the AI platform in comparison to standard manual analysis.
次要结局
- Cost-effectiveness analysis of a screening model assisted by AI(1 year after the last enrolled patient)