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Active, not recruitingNCT06528821AI-ECG-TIMIUpdated Mar 20, 2026

AI-Powered ECG Detecting Culprit Vessel Blood Flow Abnormality in ACS

An observational study in Acute Coronary Syndrome, STEMI and Coronary Occlusion, sponsored by Powerful Medical. Active, not recruiting at 9 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Powerful Medical · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years to 85 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • 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)
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In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's planned enrollment of 800 is above the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Powerful Medical is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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)

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Target follow-up
1 Week
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Index hospitalization (assessed up to 5 days)

Secondary outcomes

  1. Subgroup Performance

    AI-ECG TIMI AI Model's performance across subgroups 1. Demographic 2. Risk factors \& co-morbidities 3. Electrocardiographic 4. Culprit artery territory

    Time frame: Index hospitalization (assessed up to 5 days)

  2. Correlate established definitions of occlusion myocardial infarction (OMI) to myocardial perfusion status

    2\. OMI definitions using routine angiographic and laboratory parameters will be correlated to abnormal myocardial perfusion using correlation coefficients.

    Time frame: Index hospitalization (assessed up to 5 days)

  3. ECG prediction of mechanical reperfusion

    a. Correlation of AI-ECG TIMI model's raw numeric predictions (between 0 and 1) with myocardial perfusion grading post PCI.

    Time frame: Index hospitalization (assessed up to 5 days)

  4. Assessment of expert ECG interpretation blinded to all clinical information

    1. Accuracy, sensitivity, specificity, positive and negative predictive value of expert interpretation of active OMI, reperfused OMI and entirety of OMI 2. Inter-rater variability of expert interpretation of active OMI, reperfused OMI and entirety of OMI.

    Time frame: Index hospitalization (assessed up to 5 days)

  5. STEMI-equivalent ECG patterns

    a. Prevalence of STEMI equivalent ECG patterns and their correlation to TIMI flow grade at angiography.

    Time frame: Index hospitalization (assessed up to 5 days)

  6. Subgroup analysis of NSTEMI-OMI patients

    9\. 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

    Time frame: Index hospitalization (assessed up to 5 days)

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Study locations

9 sites
  • LKH Hochsteiermark, Standort Bruck
    Bruck an der Mur, Austria
  • LKH II Standort West
    Graz, 8020, Austria
  • Medical University of Graz
    Graz, Austria
  • OLV Aalst
    Aalst, Belgium
  • AZ Sint Jan
    Bruges, Belgium
  • Jessa Ziekenhuis
    Hasselt, Belgium
  • University Hospital D'Annunzio Chieti
    Chieti, Italy
  • San Pietro Hospital
    Rome, Italy
  • Sant´Andrea Hospital
    Rome, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06528821
Lead sponsor
Powerful Medical
Responsible party
Sponsor
First posted
Jul 30, 2024
Start date
Dec 10, 2024
Primary completion
Mar 16, 2026
Completion
May 16, 2026 (estimated)
Last update
Mar 20, 2026

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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