Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06528821

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Coronary Syndrome Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Coronary Disease Coronary Occlusion Coronary Syndrome Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia NSTEMI NSTEMI - Non-ST Segment Elevation MI Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction STEMI Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH Hochsteiermark, Standort Bruck, Bruck an der Mur, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Subgroup Performance

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

    AI-ECG TIMI AI Model's performance across subgroups

    • Demographic
    • Risk factors & co-morbidities
    • Electrocardiographic
    • Culprit artery territory

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

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

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

  3. ECG prediction of mechanical reperfusion

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

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

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

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

    • 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.

  5. STEMI-equivalent ECG patterns

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

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

  6. Subgroup analysis of NSTEMI-OMI patients

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

    • 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

Sponsors and collaborators

Lead sponsor

Powerful Medical

Other

Registry information

Official study title

Artificial Intelligence-Powered Electrocardiogram Detecting Culprit Vessel Blood Flow Abnormality in Acute Coronary Syndromes

Acronym: AI-ECG-TIMI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.