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

NCT06528821 | Active Not Recruiting DMC

• 1 other identifier: AI-ECG-TIMI_v1
• Study Type: observational
• Target: 800
• Locations: 3 countries
• Sites: 9

Brief 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.

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)

Outcome Measures

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.

  Index hospitalization (assessed up to 5 days)

Secondary Outcomes (6)

• Subgroup Performance

  Index hospitalization (assessed up to 5 days)

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

  Index hospitalization (assessed up to 5 days)

• ECG prediction of mechanical reperfusion

  Index hospitalization (assessed up to 5 days)

• Assessment of expert ECG interpretation blinded to all clinical information

  Index hospitalization (assessed up to 5 days)

• STEMI-equivalent ECG patterns

  Index hospitalization (assessed up to 5 days)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Powerful Medical: lead

Study Sites (9)

LKH Hochsteiermark, Standort Bruck

Bruck an der Mur, Austria

Location

LKH II Standort West

Graz, 8020, Austria

Location

Medical University of Graz

Graz, Austria

Location

OLV Aalst

Aalst, Belgium

Location

AZ Sint Jan

Bruges, Belgium

Location

Jessa Ziekenhuis

Hasselt, Belgium

Location

University Hospital D'Annunzio Chieti

Chieti, Italy

Location

San Pietro Hospital

Rome, Italy

Location

Sant´Andrea Hospital

Rome, Italy

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Coronary Occlusion; Angina, Unstable; Non-ST Elevated Myocardial Infarction; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Robert Herman, MD, PhD

  Powerful Medical

  PRINCIPAL INVESTIGATOR

• Emanuele Barbato, MD, PhD

  University of Roma La Sapienza

  STUDY CHAIR

• Jozef Bartunek, MD, PhD

  Azorg Hospital, Aalst

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 30, 2024
• Study Start: December 10, 2024
• Primary Completion: March 16, 2026
• Study Completion (Estimated): May 16, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); BE (3); IT (3)