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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Coronary Syndrome; Coronary Occlusion; STEMI; NSTEMI - Non-ST Segment Elevation MI; Coronary Syndrome; NSTEMI

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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)

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Index hospitalization (assessed up to 5 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subgroup Performance	AI-ECG TIMI AI Model's performance across subgroups; Demographic; Risk factors & co-morbidities; Electrocardiographic; Culprit artery territory	Index hospitalization (assessed up to 5 days)
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.	Index hospitalization (assessed up to 5 days)
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.	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.	Index hospitalization (assessed up to 5 days)
STEMI-equivalent ECG patterns	a. Prevalence of STEMI equivalent ECG patterns and their correlation to TIMI flow grade at angiography.	Index hospitalization (assessed up to 5 days)
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	Index hospitalization (assessed up to 5 days)

Collaborators and Investigators

• Sponsor: Powerful Medical
• Investigators: Principal Investigator: Robert Herman, MD, PhD, Powerful Medical; Study Chair: Emanuele Barbato, MD, PhD, University of Roma La Sapienza; Study Chair: Jozef Bartunek, MD, PhD, Azorg Hospital, Aalst

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Actual): March 16, 2026
• Study Completion (Estimated): May 16, 2026

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Acute Coronary Syndrome; ECG; Myocardial Infarction (MI); Occlusion Myocardial Infarction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Coronary Disease; Myocardial Ischemia; Ischemia; Chest Pain; Angina Pectoris; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable; Coronary Occlusion
• Other Study ID Numbers: AI-ECG-TIMI_v1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No