Coronary Arterial Disease (CAD)ANOMINCT06910436
Artificial Intelligence Based Timing, Infarct Size and Outcomes in Acute Coronary Occlusion Myocardial Infarction
An observational study of Coronary Arterial Disease (CAD) and Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), run by Azienda Ospedaliera di Bolzano at 1 site in Italy.
Trial summary
The present study is practice-driven and merely observational and prospective. In clinical routine, patients who suffer from suspected ACS and do not show ST elevation in the ECG, different timing proposals in the guidelines and logistically driven differences lead to considerably variable timings in invasive coronary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
- What is being tested?
- Coronary Angiogram
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2024to 31 Jul 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 presenting with chest pain and deemed as Non-ST Elevation Myocardial Infarction by the specialist, whether in the emergency medicine setting or in-hospital
Who may be able to join
- Age > 18 yrs
- Working diagnosis of Non- ST Elevation Acute Coronary Syndrome after the assessment by specialist
Who cannot join
- ST-Elevation Myocardial infarction
- Age < 18 yrs
- Major sustained ventricular arrhythmias
- Corrupted ECG images
- Poor digitalisation quality of the ECG
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Sanitaria di Bolzano
Bolzano, BZ, 39100
Matthias MU Unterhuber, Assoc.Prof. Dr. Dr., +39 0471 94 9950, matthias.unterhuber@sabes.it
About this study
Official title: Artificial Intelligence Based Timing, Infarct Size and Outcomes in Acute Coronary Occlusion Myocardial Infarction Without ST Elevation
The present study is practice-driven and merely observational and prospective. In clinical routine, patients who suffer from suspected ACS and do not show ST elevation in the ECG, different timing proposals in the guidelines and logistically driven differences lead to considerably variable timings in invasive coronary anatomy assessments. This handling may lead to larger infarct sizes when OMI is overseen. Therefore, the present study aims to observe a) whether an AI model is capable of correctly identify OMI in eligible patients and b) if in these patients troponin peak levels vary depending on the elapsed time between OMI diagnosis and coronary intervention.
As the model has not been established yet clinically and in the guidelines, it is safe to assume the usual pathway from first medical contact to specialist's attention is undertaken. When a patient presents in an emergency department or places an emergency call, the physicians assess the situation as usal and as stated in the current guidelines1.
Read more
If no STEMI is confirmed, the NSTE-ACS protocol is started. The patients who are ruled out for ACS are excluded from the final analysis (screening). In this case, the AI model is tested on their ECG in order to assess whether there are false positives.
The patients which are in the ACS "rule-in" trail and undergo final coronary angiography will naturally be divided in patients which were classified as OMI and as non-OMI by the AI model. Furthermore, they will present a different "Time from OMI diagnosis to PCI) and variable troponin peak levels.
By leveraging this natural variability, a practical distinction and multiple analyses can be done:
- The feasibility of AI-powered ECG interpretation in the care of patients with suspected ACS and without clear ST-elevation infarction
- The accuracy of AI-powered ECG interpretation in detecting OMI compared to the classical STEMI criteria
- How infarct size correlates with different ECG readings by AI and (hypothesis generating) if changing the clinical practice could lead to a benefit in patients with suspected OMI.
Read the detailed description
The 12-lead electrocardiogram (ECG) is the most widely used initial diagnostic tool to guide the management of patients with suspected acute coronary syndrome (ACS). At present, ACS is divided into ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation acute coronary syndrome (NSTE-ACS), with different treatment protocols. However, some patients with NSTE-ACS have an acute coronary occlusion (OMI) and may benefit from immediate reperfusion by percutaneous coronary intervention (PCI), but are often treated late. ECG signs suggestive of OMI have been described, but their visual interpretation by experts is variable and suboptimal. Recent studies have shown that artificial intelligence (AI) models for ECG analysis can outperform clinicians in the detection of OMI, suggesting the potential use of AI to improve triage and timely access to PCI. The investigators therefore aim to use these models to analyze ECGs of Patients with NSTE-ACS and to check whether the model outputs OMI or not OMI. Based on that information, the investigators will analyze the time it had taken from admission to intervention (PCI), in order to correlate possible late reperfusions with infarct size of the ventricle. The hypothesis is that a occluded coronary artery will in fact produce a larger infarct size (scar) in the ventricle after longer occlusion times (=reperfusion time), therefore the patients will be dichotomized in early and late intervention patients and analyzed based on their infarct size and outcome, stratified by the OMI diagnosis made by the AI ECG algorithm.
- Conditions
- Coronary Arterial Disease (CAD), Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
- Being tested
- Coronary Angiogram
- Keywords
- Artificial Intelligence, ECG, AI, NSTE-ACS, ACS, Acute Coronary Syndrome, Reperfusion times, PCI, Percutaneous Coronary Intervention
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary AngiogramDiagnostic test
Diagnostic/therapeutic procedure to reopen an occluded coronary artery by inflating a balloon and inserting a stent
| Study group | Role | What they receive |
|---|---|---|
| NSTE-ACS | Patients with Non ST-Elevation myocardial infarction Receives: Diagnostic Test: Coronary Angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Mortality
Cardiovascular Mortality
Measured: 12 months
Infarct Size
Infarct size measured by transthoracic echocardiogram or cardiac magnetic resonance imaging
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Apr 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies 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
- 1,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Bolzano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Unterhuber, Azienda Ospedaliera di Bolzano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910436
- Sponsor's protocol ID
- ANOMI
- Acronym
- ANOMI
- Status last verified
- May 2026
- First submitted
- 28 Mar 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The trial is investigator initiated and patient privacy is of paramount importance.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Based Timing, Infarct Size and Outcomes in Acute Coronary Occlusion Myocardial Infarction Without ST Elevation
- ClinicalTrials.gov ID
- NCT06910436
- Acronym / sponsor ID
- ANOMI / ANOMI
- Conditions
- Coronary Arterial Disease (CAD), Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
- Keywords
- Artificial Intelligence, ECG, AI, NSTE-ACS, ACS, Acute Coronary Syndrome, Reperfusion times, PCI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di BolzanoUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 4 Apr 2025 (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.
The present study is practice-driven and merely observational and prospective. In clinical routine, patients who suffer from suspected ACS and do not show ST elevation in the ECG, different timing proposals in the guidelines and logistically driven differences lead to considerably variable timings in invasive coronary anatomy assessments. This handling may lead to larger infarct sizes when OMI is overseen. Therefore, the present study aims to observe a) whether an AI model is capable of correctly identify OMI in eligible patients and b) if in these patients troponin peak levels vary depending on the elapsed time between OMI diagnosis and coronary intervention.
As the model has not been established yet clinically and in the guidelines, it is safe to assume the usual pathway from first medical contact to specialist's attention is undertaken. When a patient presents in an emergency department or places an emergency call, the physicians assess the situation as usal and as stated in the current guidelines1.
If no STEMI is confirmed, the NSTE-ACS protocol is started. The patients who are ruled out for ACS are excluded from the final analysis (screening). In this case, the AI model is tested on their ECG in order to assess whether there are false positives.
The patients which are in the ACS "rule-in" trail and undergo final coronary angiography will naturally be divided in patients which were classified as OMI and as non-OMI by the AI model. Furthermore, they will present a different "Time from OMI diagnosis to PCI) and variable troponin peak levels.
By leveraging this natural variability, a practical distinction and multiple analyses can be done:
- The feasibility of AI-powered ECG interpretation in the care of patients with suspected ACS and without clear ST-elevation infarction
- The accuracy of AI-powered ECG interpretation in detecting OMI compared to the classical STEMI criteria
- How infarct size correlates with different ECG readings by AI and (hypothesis generating) if changing the clinical practice could lead to a benefit in patients with suspected OMI.
Detailed description
The 12-lead electrocardiogram (ECG) is the most widely used initial diagnostic tool to guide the management of patients with suspected acute coronary syndrome (ACS). At present, ACS is divided into ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation acute coronary syndrome (NSTE-ACS), with different treatment protocols. However, some patients with NSTE-ACS have an acute coronary occlusion (OMI) and may benefit from immediate reperfusion by percutaneous coronary intervention (PCI), but are often treated late. ECG signs suggestive of OMI have been described, but their visual interpretation by experts is variable and suboptimal. Recent studies have shown that artificial intelligence (AI) models for ECG analysis can outperform clinicians in the detection of OMI, suggesting the potential use of AI to improve triage and timely access to PCI. The investigators therefore aim to use these models to analyze ECGs of Patients with NSTE-ACS and to check whether the model outputs OMI or not OMI. Based on that information, the investigators will analyze the time it had taken from admission to intervention (PCI), in order to correlate possible late reperfusions with infarct size of the ventricle. The hypothesis is that a occluded coronary artery will in fact produce a larger infarct size (scar) in the ventricle after longer occlusion times (=reperfusion time), therefore the patients will be dichotomized in early and late intervention patients and analyzed based on their infarct size and outcome, stratified by the OMI diagnosis made by the AI ECG algorithm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSTE-ACS | – | Diagnostic Test: Coronary AngiogramPatients with Non ST-Elevation myocardial infarction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with chest pain and deemed as Non-ST Elevation Myocardial Infarction by the specialist, whether in the emergency medicine setting or in-hospital
Key inclusion criteria (2 listed)
- Age > 18 yrs
- Working diagnosis of Non- ST Elevation Acute Coronary Syndrome after the assessment by specialist
Key exclusion criteria (5 listed)
- ST-Elevation Myocardial infarction
- Age < 18 yrs
- Major sustained ventricular arrhythmias
- Corrupted ECG images
- Poor digitalisation quality of the ECG
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 |
|---|---|---|
| Coronary AngiogramDiagnostic/therapeutic procedure to reopen an occluded coronary artery by inflating a balloon and inserting a stent | Diagnostic test | NSTE-ACS |
Primary outcome
Cardiovascular Mortality
Time frame: 12 months
Cardiovascular Mortality
Infarct Size
Time frame: 12 months
Infarct size measured by transthoracic echocardiogram or cardiac magnetic resonance imaging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. The trial is investigator initiated and patient privacy is of paramount importance.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD) and Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), run by Azienda Ospedaliera di Bolzano at 1 site in Italy.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthias Unterhuber, MD, Associate Prof. (+39 471 43 9950, matthias.unterhuber@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Mortality (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2026.