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

NCT05689970 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 420

Last updated 2024-03-06

No results posted yet for this 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.

Conditions

  • STEMI - ST Elevation Myocardial Infarction

Interventions

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.

Sponsors & Collaborators

  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER

  • Spanish Society of Cardiology

    collaborator OTHER

  • Idoven 1903 S.L.

    lead INDUSTRY

Principal Investigators

  • Manuel Martínez-Sellés, MD · Hospital Universitario Gregorio Marañón

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-25
Primary Completion
2024-01-25
Completion
2024-07-24

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05689970 on ClinicalTrials.gov