NCT05689970

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

LESTONNAC Study: Observed ST Elevation Does Not Require Acute Cardiac Necrosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 420 (estimated)
• Sponsor: Idoven 1903 S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• STEMI - ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AI platform to detect ST elevation in ECG	A clinical decision support software as a medical device that detects whether a patient has ST elevation due to acute myocardial ischemia or due to another etiology based upon the input of one or more ECGs and other clinical data obtained at the point-of-care.

Timeline

• Start date: 2022-07-25
• Primary completion: 2024-01-25
• Completion: 2024-07-24
• First posted: 2023-01-19
• Last updated: 2024-03-06

Locations

7 sites across 1 country: Spain