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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-25

Study Completion Date

2024-07-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Artificial Intelligence Based Timing, Infarct Size and Outcomes in Acute Coronary Occlusion Myocardial Infarction

NCT06910436

Coronary Arterial Disease (CAD) Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)

RECRUITING

EROSION III: OCT- vs Angio-based Reperfusion Strategy for STEMI

NCT03571269

ST-segment Elevation Myocardial Infarction

COMPLETED NA

3D-QFR in Non-selected Angiographic Stenosis. A Spanish Multicentre Study.

NCT05251012

Coronary Stenosis Coronary Artery Disease

COMPLETED

Effectiveness of the Anatomical Snuff Box Approach for Coronary Angiography

NCT05725616

Coronary Angiography

COMPLETED NA

Stress Echocardiography Versus Coronary Angiography for Left Main Stenosis Detection

NCT01620320

Left Main Coronary Artery Disease Stenosis

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

STEMI - ST Elevation Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

AI platform to detect ST elevation in ECG

Intervention Type DIAGNOSTIC_TEST

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.

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.

AI platform to detect ST elevation in ECG

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Willem platform Idoven AI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No