Improving diagnosis of anomalous coronary arteries
SMART: Speed-up the Diagnosis and Evaluation of anoMalous Coronary ARTery From the Aorta.
NA · IRCCS Policlinico S. Donato · NCT06705751
This study is testing a new online tool that uses advanced technology to help doctors better diagnose and understand the risks for patients with unusual heart artery conditions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato (other) |
| Locations | 1 site (San Donato Milanese, Italia) |
| Trial ID | NCT06705751 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance the diagnosis and evaluation of anomalous aortic origin of the coronary arteries (AAOCA) using advanced technologies such as machine learning and artificial intelligence. A web-based platform will be developed to process anonymized Computed Tomography Angiography (CTA) images, allowing for automatic segmentation and identification of anomalous coronary origins. The platform will integrate anatomical measurements with clinical data to assess the risk of sudden cardiac death and major ischemic events. This innovative approach seeks to provide a more accurate and personalized risk stratification for patients with AAOCA.
Who should consider this trial
Good fit: Ideal candidates include adults and pediatric patients over 6 years old with a confirmed diagnosis of anomalous coronary origin from the aorta.
Not a fit: Patients with acute inflammatory conditions, arrhythmias, or contraindications to autonomic testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to earlier and more accurate diagnosis of AAOCA, potentially reducing the risk of sudden cardiac events in affected patients.
How similar studies have performed: Other studies utilizing advanced imaging and AI for cardiac conditions have shown promising results, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult and pediatric patients (age \> 6 years) with anomalous coronary origin from the aorta (AAOCA). * Patients in spontaneous sinus rhythm. * Signed informed consent. Exclusion Criteria: * Patients with acute and chronic inflammatory conditions such as chronic liver disease, chronic kidney failure (creatinine \> 1.5 mg/dl), and thyroid disorders. * Patients with arrhythmias, absence of sinus rhythm. * Contraindications to autonomic testing. * Patients with a known allergy to materials in recording devices. * Female patients who are pregnant.
Where this trial is running
San Donato Milanese, Italia
- IRCCS Policlinico San Donato — San Donato Milanese, Italia, Italy (RECRUITING)
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.
Conditions: AAOCA, ACAOS, Anomalous Aortic Origin of the Coronary Artery, Anomalous Coronary Artery Arising From the Opposite Sinus, Anomalous Coronary Artery Origin, Anomalous Coronary Artery With Aortic Origin and Course Between the Great Arteries, Coronary Anomaly, Sudden Cardiac Death