AI technology for detecting blood flow issues in heart patients
Artificial Intelligence-Powered Electrocardiogram Detecting Culprit Vessel Blood Flow Abnormality in Acute Coronary Syndromes
This study is testing whether an AI tool can help doctors spot blood flow problems in heart patients with acute coronary syndrome by looking at their ECG results before a heart procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Powerful Medical Academic / other |
| Locations | 9 sites (Bruck an der Mur and 8 other locations) |
| Trial ID | NCT06528821 on ClinicalTrials.gov |
What this trial studies
This study is an international, multicenter registry focused on patients with acute coronary syndrome (ACS). It aims to utilize an artificial intelligence model to analyze electrocardiographic (ECG) findings that can predict alterations in coronary blood flow during invasive coronary angiography. By assessing the TIMI grade flow at the time of angiography, the study seeks to improve the identification of critical blood flow abnormalities in ACS patients. The study includes patients who have undergone a standard 12-lead ECG prior to the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are experiencing acute coronary syndromes and are scheduled for invasive coronary angiography.
Not a fit: Patients presenting for non-emergent cardiac catheterization or those with chronic coronary syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing blood flow abnormalities in patients with acute coronary syndrome, leading to better treatment outcomes.
How similar studies have performed: While the use of AI in ECG analysis is a growing field, this specific approach to predicting coronary blood flow alterations in ACS patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bruck an der Mur and 8 other locations
- LKH Hochsteiermark, Standort Bruck — Bruck an der Mur, Austria (Not_yet_recruiting)
- LKH II Standort West — Graz, Austria (Not_yet_recruiting)
- Medical University of Graz — Graz, Austria (Recruiting)
- OLV Aalst — Aalst, Belgium (Recruiting)
- AZ Sint Jan — Brugge, Belgium (Recruiting)
- Jessa Ziekenhuis — Hasselt, Belgium (Recruiting)
- University Hospital D'Annunzio Chieti — Chieti, Italy (Recruiting)
- San Pietro Hospital — Rome, Italy (Recruiting)
- Sant´Andrea Hospital — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Robert Herman, MD, PhD — Powerful Medical
- Study coordinator: Timea Kisova, MD
- Email: tkisova@powerfulmedical.com
- Phone: +421901766801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.