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

Last updated: March 4, 2024
Sponsor: Idoven 1903 S.L.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Occlusions

Circulation Disorders

Treatment

AI platform to detect ST elevation in ECG

Clinical Study ID

NCT05689970
350/21
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 infarctioncode in two contiguous leads ≥0.1 mV, in V2 and V3 ≥0.2 mV.
  • Signature of informed consent.

Exclusion

Exclusion Criteria:

  • Left bundle branch block.
  • Acute cardiac necrosis in the absence of significant epicardial coronary arterystenosis >70% (vasospasm, takotsubo stress cardiomyopathy, myocarditis, coronaryartery 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).

Study Design

Total Participants: 420
Treatment Group(s): 1
Primary Treatment: AI platform to detect ST elevation in ECG
Phase:
Study Start date:
July 25, 2022
Estimated Completion Date:
July 24, 2024

Study 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.

Connect with a study center

  • Hospital Universitario de Canarias

    La Laguna, Santa Cruz De Tenerife 38320
    Spain

    Site Not Available

  • Hospital de Basurto

    Bilbao, Vizcaya 48013
    Spain

    Site Not Available

  • Hospital Vall D' Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Idoven

    Madrid, 28002
    Spain

    Site Not Available

  • Servicio Cardiología Hospital Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003
    Spain

    Site Not Available

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