Clinical trial NCT06528821: AI-Powered ECG Detecting Culprit Vessel Blood Flow Abnormality in ACS
Official title: Artificial Intelligence-Powered Electrocardiogram Detecting Culprit Vessel Blood Flow Abnormality in Acute Coronary Syndromes
Study type: OBSERVATIONAL
Overall status: RECRUITING
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)
Lead sponsor: Powerful Medical
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Accuracy of the AI-ECG TIMI AI Model
timeFrame: Index hospitalization (assessed up to 5 days)
Secondary outcomes:
measure: Subgroup Performance
timeFrame: Index hospitalization (assessed up to 5 days)
measure: Correlate established definitions of occlusion myocardial infarction (OMI) to myocardial perfusion status
timeFrame: Index hospitalization (assessed up to 5 days)
measure: ECG prediction of mechanical reperfusion
timeFrame: Index hospitalization (assessed up to 5 days)
measure: Assessment of expert ECG interpretation blinded to all clinical information
timeFrame: Index hospitalization (assessed up to 5 days)
measure: STEMI-equivalent ECG patterns
timeFrame: Index hospitalization (assessed up to 5 days)
measure: Subgroup analysis of NSTEMI-OMI patients
timeFrame: Index hospitalization (assessed up to 5 days)
Other outcomes:
Locations:
city: Bruck an der Mur
country: Austria
facility: LKH Hochsteiermark, Standort Bruck
city: Graz
country: Austria
facility: LKH II Standort West
city: Graz
country: Austria
facility: Medical University of Graz
city: Aalst
country: Belgium
facility: OLV Aalst
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Chieti
country: Italy
facility: University Hospital D'Annunzio Chieti
city: Rome
country: Italy
facility: San Pietro Hospital
city: Rome
country: Italy
facility: Sant´Andrea Hospital
Study officials:
affiliation: Powerful Medical
name: Robert Herman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Roma La Sapienza
name: Emanuele Barbato, MD, PhD
role: STUDY_CHAIR
affiliation: Azorg Hospital, Aalst
name: Jozef Bartunek, MD, PhD
role: STUDY_CHAIR
References: