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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: f
View:

• Adult and pediatric patients (age \> 6 years) with anomalous coronary origin from the aorta (AAOCA).

• Patients in spontaneous sinus rhythm.

• Signed informed consent.

Locations
Other Locations
Italy
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
Time Frame
Start Date: 2024-09-12
Estimated Completion Date: 2026-08
Participants
Target number of participants: 38
Treatments
Experimental: Prospective study
The prospective phase aims to validate the entire model developed during the retrospective phase and to evaluate the role of autonomic response in subjects with Anomalous Aortic Origin of a Coronary Artery (AAOCA). The prospective recruitment of the cohort of AAOCA patients for autonomic assessment and validation will span the entire duration of the study. Our objective is to recruit 38 patients with AAOCA to obtain consistent and uniform data from at least 32 participants. Patients in this cohort will undergo an active standing test to elicit an autonomic response, and the results will be compared with reference normal values.~During this examination, the following data will be collected: continuous ECG, non-invasive blood pressure, and respiratory measurements in both supine and prone positions.
Sponsors
Collaborators: University of Pavia, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, University of Naples
Leads: IRCCS Policlinico S. Donato

This content was sourced from clinicaltrials.gov