STEMI - ST Elevation Myocardial InfarctionLESTONNACNCT05689970
ST-segment Elevation Not Associated With Acute Cardiac Necrosis (LESTONNAC)
An observational study of STEMI - ST Elevation Myocardial Infarction, run by Idoven 1903 S.L. at 7 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- AI platform to detect ST elevation in ECG
- How many people
- 420 participants
- Where
- 7 sitesSpain
- Study dates
- 25 Jul 2022to 24 Jul 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients going to the hospital with suspected symptoms of myocardial infarction and ST segment elevation in the electrocardiogram.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Vall D' Hebron
Barcelona, 08035
Hospital de Basurto
Bilbao, Vizcaya, 48013
Idoven
Madrid, 28002
Servicio Cardiología Hospital Universitario Gregorio Marañón
Madrid, 28007
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
About this study
Official title: 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.
Read the 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.
- Being tested
- AI platform to detect ST elevation in ECG
- Keywords
- ST segment elevation, Artificial intelligence, Electrocardiogram, Acute myocardial infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI platform to detect ST elevation in ECGDiagnostic test
Also called Willem platform, Idoven AI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Diagnostic Test: AI platform to detect ST elevation in ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after the last enrolled patient
Secondary outcomes (1)
Cost-effectiveness analysis of a screening model assisted by AI
The benefits of the screening model assisted by the AI platform will be evaluated using a hybrid decision tree/ Markov model.
Measured: 1 year after the last enrolled patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start25 Jul 2022
- Primary completion25 Jan 2024
- Study completion24 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Idoven 1903 S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital General Universitario Gregorio Marañon, Spanish Society of Cardiology
- Responsible party
- Sponsor
- Investigators
- Manuel Martínez-Sellés, MD, Principal investigator, Hospital Universitario Gregorio Marañón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689970
- Sponsor's protocol ID
- 350/21
- Acronym
- LESTONNAC
- Status last verified
- Mar 2024
- First submitted
- 20 Dec 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18775237Lillo-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.
PubMed 31840163Quartieri 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.
PubMed 36310681
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LESTONNAC Study: Observed ST Elevation Does Not Require Acute Cardiac Necrosis
- ClinicalTrials.gov ID
- NCT05689970
- Acronym / sponsor ID
- LESTONNAC / 350/21
- Keywords
- ST segment elevation, Artificial intelligence, Electrocardiogram, Acute myocardial infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Idoven 1903 S.L.Industry (pharma, biotech, devices)
- Collaborators
- Hospital General Universitario Gregorio Marañon, Spanish Society of Cardiology
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 24 Jul 2024 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STE patients | – | Diagnostic Test: AI platform to detect ST elevation in ECGPatients 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). |
| STEMI patients | – | Diagnostic Test: AI platform to detect ST elevation in ECGPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients going to the hospital with suspected symptoms of myocardial infarction and ST segment elevation in the electrocardiogram.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI platform to detect ST elevation in ECGAlso: Willem platform, Idoven AIA 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. | Diagnostic test | STE patients, STEMI patients |
Primary outcome
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.
1 secondary outcome
Cost-effectiveness analysis of a screening model assisted by AI
Time frame: 1 year after the last enrolled patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 18775237Martinez-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.
- Background: PubMed 31840163Lillo-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.
- Background: PubMed 36310681Quartieri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Martínez-Sellés, MD principal investigator
Hospital Universitario Gregorio Marañón
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI - ST Elevation Myocardial Infarction, run by Idoven 1903 S.L. at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical validation of a screening model assisted by AI (time frame: 6 months after the last enrolled patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05689970, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.