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

NCT ID: NCT06528821

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-10

Study Completion Date

2025-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Coronary Syndrome STEMI Coronary Occlusion Coronary Syndrome NSTEMI NSTEMI - Non-ST Segment Elevation MI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Powerful Medical

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Herman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Powerful Medical

Emanuele Barbato, MD, PhD

Role: STUDY_CHAIR

University of Roma La Sapienza

Jozef Bartunek, MD, PhD

Role: STUDY_CHAIR

Azorg Hospital, Aalst

Locations

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LKH Hochsteiermark, Standort Bruck

Bruck an der Mur, , Austria

Site Status NOT_YET_RECRUITING

LKH II Standort West

Graz, , Austria

Site Status NOT_YET_RECRUITING

Medical University of Graz

Graz, , Austria

Site Status RECRUITING

OLV Aalst

Aalst, , Belgium

Site Status RECRUITING

AZ Sint Jan

Bruges, , Belgium

Site Status RECRUITING

Jessa Ziekenhuis

Hasselt, , Belgium

Site Status RECRUITING

University Hospital D'Annunzio Chieti

Chieti, , Italy

Site Status RECRUITING

San Pietro Hospital

Rome, , Italy

Site Status RECRUITING

Sant´Andrea Hospital

Rome, , Italy

Site Status RECRUITING

Countries

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Austria Belgium Italy

Central Contacts

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Timea Kisova, MD

Role: CONTACT

+421901766801

Facility Contacts

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Gert Klug, Prim. Dr.

Role: primary

Martin Genger, Prim. Dr.

Role: primary

Gabor Toth, MD

Role: primary

Adriaan Wilgenhof, MD

Role: primary

Ian Buysschaert, MD

Role: primary

Pascal Vranckx, MD

Role: primary

Fabrizio Ricci, MD, PhD

Role: primary

Dario Bertolone, MD

Role: primary

Marta Belmonte, MD

Role: primary

Other Identifiers

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AI-ECG-TIMI_v1

Identifier Type: -

Identifier Source: org_study_id

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