Anomalous Aortic Origin of Coronary Artery

NCT05692063 | Recruiting

• 1 other identifier: AAOCA
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This project has several objectives ranging from clinical data analysis to computational simulations as listed below: A) Clinical objectives:

1. 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. 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).
3. 3.Retrieve morphological measurements from CT or MRI (de-identified) of the aortic root and the coronary vessels following the previous work of our group.
4. 4.Construct a parametric model of the aortic root defined by population-based morphologic parameters to describe both healthy/diseased population.
5. 5.Run solid mechanics simulation mimicking the movement of the aortic root in order to test configurations at more risk.
6. 6.Reconstruct 3D surfaces representing the coronary vasculature from imaging for automatically perform the parameter estimation and run computational fluid dynamics simulations.

Conditions

Anomalous Aortic Origin of the Coronary Artery (AAOCA)

Outcome Measures

Primary Outcomes (1)

• ischemia, angina event, sudden cardiac death

  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

  10 years

Secondary Outcomes (1)

• risk factors for ischemia or sudden cardiac deaths

  10 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients (adults and pediatrics) with diagnosis of anomalous aortic origin of coronary arteries

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

Irccs Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: June 27, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)