Actively Recruiting

Phase Not Applicable
Age: 6Years +
All Genders
NCT06705751

Speed-up the Diagnosis and Evaluation of anoMalous Coronary ARTery From the Aorta

Led by IRCCS Policlinico S. Donato · Updated on 2026-04-15

38

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

Sponsors

I

IRCCS Policlinico S. Donato

Lead Sponsor

U

University of Pavia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Anomalous aortic origin of the coronary arteries (AAOCA) is a rare congenital disease and one of the leading causes of sudden cardiac deaths (SCD) in young athletes but also has a lethal presentation in adult age with myocardial infarction, even if not related to obstructive coronary arteries. Unfortunately, diagnostic imaging techniques, invasive assessment, and provocative stress tests have shown low sensitivity and specificity in detecting inducible ischemia, and a multimodality assessment is then necessary. Innovative tools have been developed in the medical field using computer-based simulation, 3-dimensional reconstruction, machine learning, and artificial intelligence (AI). With the application of such new technologies, we aim to fill the gap of knowledge and the diagnostic limitation regarding risk stratification for most subjects with AAOCA. This work seeks to enhance, fasten, and personalize the clinical diagnosis of AAOCA by integrating anatomical measurements, clinical data, and biomechanical patient-specific features. The SMART study will set a system to automatically segment and classify coronary arteries with AAOCA from computerized tomography angiography (CTA) by artificial intelligence (AI). Segmentation will feed a 3D model of the aortic root and coronary artery for biomechanical assessment through finite element analysis (FEA). This will allow us to assess the location of possible coronary artery compression under an effort condition. These in-silico results, the anatomical features measured by AI, and the clinical data will be integrated into a risk model to estimate the hazard risk of adverse events such as SCD or myocardial infarction. This workflow will be framed in an IT system to allow a web-based remote diagnostic service. Thanks to the proposed multidisciplinary approach, SMART aims to overcome the current diagnostic limitations related to the reduced ability of functional stress tests to detect ischemia. Potentially helping in patient-specific risk stratification, SMART is also thought to provide a way to get a first diagnostic indication about AAOCA being accessible from any hospital, fostering the diffusion of peripheral territorial support to the diagnosis and treatment of such rare disease.

CONDITIONS

Official Title

Speed-up the Diagnosis and Evaluation of anoMalous Coronary ARTery From the Aorta

Who Can Participate

Age: 6Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult and pediatric patients aged 6 years or older with anomalous coronary origin from the aorta (AAOCA)
  • Patients in spontaneous sinus rhythm
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Acute or chronic inflammatory conditions like chronic liver disease, chronic kidney failure (creatinine > 1.5 mg/dl), or thyroid disorders
  • Arrhythmias or absence of sinus rhythm
  • Contraindications to autonomic testing
  • Known allergy to materials in recording devices
  • Pregnant female patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Policlinico San Donato

San Donato Milanese, Italia, Italy, 20097

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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