Recruiting

AAOCAAnomalous Aortic Origin of Coronary Artery: From Pathophysiology to Risk Stratification Through a Patient Specific Computational Simulation Model

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2019
See protocol details

Summary

Principal SponsorIRCCS Policlinico S. Donato
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 27, 2019

Actual date on which the first participant was enrolled.

This project has several objectives ranging from clinical data analysis to computational simulations as listed below: A) Clinical objectives: 1. Retrospective review of all patients with AAOCA treated surgically and followed medically at the IRCCS Policlinico San Donato aiming to identify risk factors for ischemia or sudden cardiac deaths. 2. Prospective follow-up of all enrolled patients, treated and followed, in adjunct to all the new patients referred aiming to follow across the years any potential rare adverse event (ischemia, angina event, sudden cardiac death). B) Experimental objectives: 1. Retrieve morphological measurements from CT or MRI (de-identified) of the aortic root and the coronary vessels following the previous work of our group. 2. Construct a parametric model of the aortic root defined by population-based morphologic parameters to describe both healthy/diseased population. 3. Run solid mechanics simulation mimicking the movement of the aortic root in order to test configurations at more risk. 4. Reconstruct 3D surfaces representing the coronary vasculature from imaging for automatically perform the parameter estimation and run computational fluid dynamics simulations.

Official TitleAnomalous Aortic Origin of Coronary Artery: From Pathophysiology to Risk Stratification Through a Patient Specific Computational Simulation Model
Principal SponsorIRCCS Policlinico S. Donato
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

130 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * All patients (adults and pediatrics) who have been diagnosed with an anomalous aortic origin of any of the coronary arteries (AAOCA) without any other congenital heart disease and diagnosed/referred or followed at the IRCCS Policlinico San Donato. Exclusion Criteria: * Patients with other major congenital heart disease with associated coronary artery origin anomalies will be excluded. Patients with anomalous origin of the coronary artery from the pulmonary artery (ALCAPA or ARCAPA) will be excluded. Patients women who are pregnant.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Irccs Policlinico San Donato

San Donato Milanese, ItalyOpen Irccs Policlinico San Donato in Google Maps
Recruiting
One Study Center