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

March 4, 2024 updated by: Idoven 1903 S.L.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d' Hebron
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28002
        • Idoven
      • Madrid, Spain, 28007
        • Servicio Cardiología Hospital Universitario Gregorio Marañón
      • Valladolid, Spain, 47003
        • Hospital Clínico Universitario de Valladolid
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients going to the hospital with suspected symptoms of myocardial infarction and ST segment elevation in the electrocardiogram.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
STE patients
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).
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.
Other Names:
  • Willem platform
  • Idoven AI
STEMI patients
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.
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.
Other Names:
  • Willem platform
  • Idoven AI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical validation of a screening model assisted by AI
Time Frame: 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.
6 months after the last enrolled patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness analysis of a screening model assisted by AI
Time Frame: 1 year after the last enrolled patient
The benefits of the screening model assisted by the AI platform will be evaluated using a hybrid decision tree/ Markov model.
1 year after the last enrolled patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Idoven 1903 S.L.

Collaborators

Hospital General Universitario Gregorio Marañon
Spanish Society of Cardiology

Investigators

  • Principal Investigator: Manuel Martínez-Sellés, MD, Hospital Universitario Gregorio Marañón

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2022

Primary Completion (Actual)

January 25, 2024

Study Completion (Estimated)

July 24, 2024

Study Registration Dates

First Submitted

December 20, 2022

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 350/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information identifier: PubMed ID: 34763217

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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