Anomalous Aortic Origin of Coronary Artery

Recruiting

• Conditions: Anomalous Aortic Origin of the Coronary Artery (AAOCA)

• Registration Number: NCT05692063
• Lead Sponsor: IRCCS Policlinico S. Donato

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-27
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ischemia, angina event, sudden cardiac death	10 years	2. Creation of a prospective registry in which will be enrolled all patients already treated and followed in adjunct to all the new patients referred aiming to follow across the years any potential rare adverse event

Secondary Outcome Measures

Name	Time	Method
risk factors for ischemia or sudden cardiac deaths	10 years	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.

Trial Locations

Locations (1)

Irccs Policlinico San Donato; 🇮🇹 San Donato Milanese, MI, Italy