Acute Coronary SyndromeAI-ECG-TIMINCT06528821
AI-Powered ECG Detecting Culprit Vessel Blood Flow Abnormality in ACS
An observational study of Acute Coronary Syndrome and STEMI, run by Powerful Medical at 9 sites in 3 countries.
Trial summary
AI ECG TIMI is an investigator-initiated, international, and multicenter registry of acute coronary syndrome patients aimed to identify electrocardiographic findings detected by an AI model predicting coronary blood flow alteration. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome, STEMI, Coronary Occlusion
- How many people
- 800 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 10 Dec 2024to 16 May 2026
- How long will I take part?
- 1 Week
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (18 or older) with acute coronary syndrome undergoing clinically indicated invasive coronary angiography, with a standard 12-lead ECG performed at invasive coronary angiogram before percutaneous coronary intervention (maximum within 15 min before vascular access)
Who may be able to join
- Patients with acute coronary syndromes undergoing invasive coronary angiography as clinically indicated.
- Availability of a standard 12-lead ECG performed at invasive coronary angiogram before percutaneous coronary intervention (maximum within 15 min before vascular access).
- Age ≥18 years.
Who cannot join
- Individuals presenting for a non-emergent (elective) cardiac catheterization.
- Individuals presenting with chronic coronary syndrome (CCS) or stable angina symptoms.
- Individuals without symptoms suspicious for acute coronary syndromes.
- Individuals with contraindications for cardiac catheterization.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Austria3 sites
LKH Hochsteiermark, Standort Bruck
Bruck an der Mur
LKH II Standort West
Graz, 8020
Medical University of Graz
Graz
Italy3 sites
University Hospital D'Annunzio Chieti
Chieti
San Pietro Hospital
Rome
Sant´Andrea Hospital
Rome
About this study
Official title: Artificial Intelligence-Powered Electrocardiogram Detecting Culprit Vessel Blood Flow Abnormality in Acute Coronary Syndromes
AI ECG TIMI is an investigator-initiated, international, and multicenter registry of acute coronary syndrome patients aimed to identify electrocardiographic findings detected by an AI model predicting coronary blood flow alteration. The aim of the study is to identify electrocardiographic findings detected by an automated artificial intelligence (AI) model that can predict coronary blood flow alteration as assessed by the TIMI grade flow at the very moment of the invasive coronary angiography in patients with acute coronary syndromes.
- Conditions
- Acute Coronary Syndrome, STEMI, Coronary Occlusion, Coronary Syndrome, NSTEMI, NSTEMI - Non-ST Segment Elevation MI
- Keywords
- Acute Coronary Syndrome, ECG, Artificial Intelligence, Occlusion Myocardial Infarction, Myocardial Infarction (MI)
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Coronary Occlusion, Angina, Unstable, Non-ST Elevated Myocardial Infarction, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of the AI-ECG TIMI AI Model
The primary endpoint is the AI-ECG TIMI model's ability to identify patients with actively occluded (TIMI 0-1) at the time of invasive coronary angiography using only single-standard 12-lead ECGs assessed by accuracy, sensitivity, specificity, positive, negative predictive values and F1 scores.
Measured: Index hospitalization (assessed up to 5 days)
Secondary outcomes (6)
Subgroup Performance
AI-ECG TIMI AI Model's performance across subgroups
- Demographic
- Risk factors \& co-morbidities
- Electrocardiographic
- Culprit artery territory
Measured: Index hospitalization (assessed up to 5 days)
Correlate established definitions of occlusion myocardial infarction (OMI) to myocardial perfusion status
- OMI definitions using routine angiographic and laboratory parameters will be correlated to abnormal myocardial perfusion using correlation coefficients.
Measured: Index hospitalization (assessed up to 5 days)
ECG prediction of mechanical reperfusion
- Correlation of AI-ECG TIMI model's raw numeric predictions (between 0 and 1) with myocardial perfusion grading post PCI.
Measured: Index hospitalization (assessed up to 5 days)
Assessment of expert ECG interpretation blinded to all clinical information
- Accuracy, sensitivity, specificity, positive and negative predictive value of expert interpretation of active OMI, reperfused OMI and entirety of OMI
- Inter-rater variability of expert interpretation of active OMI, reperfused OMI and entirety of OMI.
Measured: Index hospitalization (assessed up to 5 days)
STEMI-equivalent ECG patterns
- Prevalence of STEMI equivalent ECG patterns and their correlation to TIMI flow grade at angiography.
Measured: Index hospitalization (assessed up to 5 days)
Subgroup analysis of NSTEMI-OMI patients
- NSTEMI-OMI stratified according to immediate (<2h) vs. SoC (>2h) invasive management, median: i. Peak troponin (maximum rise before fall) ii. Median LVEF at discharge iii. Length of hospital stay iv. Length of cardiac care unit (CCU) or intensive care unit (ICU) stay v. Presence of life-threatening arrhythmias
Measured: Index hospitalization (assessed up to 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start10 Dec 2024
- Primary completion16 Mar 2026
- Study completion16 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- 800 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Powerful Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Herman, MD, PhD, Principal investigator, Powerful MedicalEmanuele Barbato, MD, PhD, Study chair, University of Roma La SapienzaJozef Bartunek, MD, PhD, Study chair, Azorg Hospital, Aalst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528821
- Sponsor's protocol ID
- AI-ECG-TIMI_v1
- Acronym
- AI-ECG-TIMI
- Status last verified
- Mar 2026
- First submitted
- 26 Jul 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Powered Electrocardiogram Detecting Culprit Vessel Blood Flow Abnormality in Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT06528821
- Acronym / sponsor ID
- AI-ECG-TIMI / AI-ECG-TIMI_v1
- Conditions
- Acute Coronary Syndrome, STEMI, Coronary Occlusion, Coronary Syndrome, NSTEMI, NSTEMI - Non-ST Segment Elevation MI
- Keywords
- Acute Coronary Syndrome, ECG, Artificial Intelligence, Occlusion Myocardial Infarction, Myocardial Infarction (MI)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Powerful MedicalUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 16 May 2026 (estimated)
- First posted
- 30 Jul 2024 (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.
AI ECG TIMI is an investigator-initiated, international, and multicenter registry of acute coronary syndrome patients aimed to identify electrocardiographic findings detected by an AI model predicting coronary blood flow alteration. The aim of the study is to identify electrocardiographic findings detected by an automated artificial intelligence (AI) model that can predict coronary blood flow alteration as assessed by the TIMI grade flow at the very moment of the invasive coronary angiography in patients with acute coronary syndromes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (18 or older) with acute coronary syndrome undergoing clinically indicated invasive coronary angiography, with a standard 12-lead ECG performed at invasive coronary angiogram before percutaneous coronary intervention (maximum within 15 min before vascular access)
Key inclusion criteria (3 listed)
- Patients with acute coronary syndromes undergoing invasive coronary angiography as clinically indicated.
- Availability of a standard 12-lead ECG performed at invasive coronary angiogram before percutaneous coronary intervention (maximum within 15 min before vascular access).
- Age ≥18 years.
Key exclusion criteria (4 listed)
- Individuals presenting for a non-emergent (elective) cardiac catheterization.
- Individuals presenting with chronic coronary syndrome (CCS) or stable angina symptoms.
- Individuals without symptoms suspicious for acute coronary syndromes.
- Individuals with contraindications for cardiac catheterization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy of the AI-ECG TIMI AI Model
Time frame: Index hospitalization (assessed up to 5 days)
The primary endpoint is the AI-ECG TIMI model's ability to identify patients with actively occluded (TIMI 0-1) at the time of invasive coronary angiography using only single-standard 12-lead ECGs assessed by accuracy, sensitivity, specificity, positive, negative predictive values and F1 scores.
6 secondary outcomes
Subgroup Performance
Time frame: Index hospitalization (assessed up to 5 days)
Correlate established definitions of occlusion myocardial infarction (OMI) to myocardial perfusion status
Time frame: Index hospitalization (assessed up to 5 days)
ECG prediction of mechanical reperfusion
Time frame: Index hospitalization (assessed up to 5 days)
Assessment of expert ECG interpretation blinded to all clinical information
Time frame: Index hospitalization (assessed up to 5 days)
STEMI-equivalent ECG patterns
Time frame: Index hospitalization (assessed up to 5 days)
Subgroup analysis of NSTEMI-OMI patients
Time frame: Index hospitalization (assessed up to 5 days)
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 20 Mar 2026.
- 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.
Robert Herman, MD, PhD principal investigator
Powerful Medical
Emanuele Barbato, MD, PhD study chair
University of Roma La Sapienza
Jozef Bartunek, MD, PhD study chair
Azorg Hospital, Aalst
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and STEMI, run by Powerful Medical at 9 sites in 3 countries.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Austria, Belgium, 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?
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?
Diagnostic Accuracy of the AI-ECG TIMI AI Model (time frame: Index hospitalization (assessed up to 5 days)). 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 20 Mar 2026.