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

NCT05689970 | Active Not Recruiting DMC

• 1 other identifier: 350/21
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

ST segment elevation; Artificial intelligence; Electrocardiogram; Acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Clinical validation of a screening model assisted by AI

  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 Outcomes (1)

• Cost-effectiveness analysis of a screening model assisted by AI

  1 year after the last enrolled patient

Study Arms (2)

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

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

Interventions

AI platform to detect ST elevation in ECG 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.

Also known as: Willem platform, Idoven AI

STE patients; STEMI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Idoven 1903 S.L.: lead
• Hospital General Universitario Gregorio Marañon: collaborator
• Spanish Society of Cardiology: collaborator

Study Sites (7)

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Hospital Vall D' Hebron

Barcelona, 08035, Spain

Location

Idoven

Madrid, 28002, Spain

Location

Servicio Cardiología Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Related Publications (3)

• Martinez-Selles M, Bueno H, Sacristan A, Estevez A, Ortiz J, Gallego L, Fernandez-Aviles F. Chest pain in the emergency department: incidence, clinical characteristics and risk stratification. Rev Esp Cardiol. 2008 Sep;61(9):953-9. English, Spanish.

  PMID: 18775237 BACKGROUND

• Lillo-Castellano JM, Gonzalez-Ferrer JJ, Marina-Breysse M, Martinez-Ferrer JB, Perez-Alvarez L, Alzueta J, Martinez JG, Rodriguez A, Rodriguez-Perez JC, Anguera I, Vinolas X, Garcia-Alberola A, Quintanilla JG, Alfonso-Almazan JM, Garcia J, Borrego L, Canadas-Godoy V, Perez-Castellano N, Perez-Villacastin J, Jimenez-Diaz J, Jalife J, Filgueiras-Rama D. Personalized monitoring of electrical remodelling during atrial fibrillation progression via remote transmissions from implantable devices. Europace. 2020 May 1;22(5):704-715. doi: 10.1093/europace/euz331.

  PMID: 31840163 BACKGROUND

• Quartieri F, Marina-Breysse M, Pollastrelli A, Paini I, Lizcano C, Lillo-Castellano JM, Grammatico A. Artificial intelligence augments detection accuracy of cardiac insertable cardiac monitors: Results from a pilot prospective observational study. Cardiovasc Digit Health J. 2022 Aug 4;3(5):201-211. doi: 10.1016/j.cvdhj.2022.07.071. eCollection 2022 Oct.

  PMID: 36310681 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Manuel Martínez-Sellés, MD

  Hospital Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 19, 2023
• Study Start: July 25, 2022
• Primary Completion: January 25, 2024
• Study Completion: July 24, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)