ST-segment Elevation Not Associated With Acute Cardiac Necrosis (LESTONNAC)

Idoven

Status: Active, not recruiting

Conditions: STEMI - ST Elevation Myocardial Infarction

Treatments: Diagnostic Test: AI platform to detect ST elevation in ECG

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05689970

350/21

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

420 participants in 2 patient groups

STE patients

Description:

Patients with ST segment elevation (STE) and coronary arteries without significant lesions and without a serum troponin curve suggestive of acute necrosis (group without acute myocardial necrosis).

Treatment:

Diagnostic Test: AI platform to detect ST elevation in ECG

STEMI patients

Description:

Patients with ST segment elevation with acute occlusion of at least one epicardial coronary artery and TIMI flow 0 or I (group with acute myocardial necrosis of ischemic origin), that meet the definition of myocardial infarction (STEMI) with an acute cardiac necrosis curve verified by measurement of troponin I or troponin T.

Treatment:

Diagnostic Test: AI platform to detect ST elevation in ECG