AAOCA: Anomalous Aortic Origin of Coronary Artery

Sponsor
IRCCS Policlinico S. Donato (Other)
Overall Status
Recruiting
CT.gov ID
NCT05692063
Collaborator
(none)
130
1
59.2
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    130 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Anomalous Aortic Origin of Coronary Artery: From Pathophysiology to Risk Stratification Through a Patient Specific Computational Simulation Model
    Actual Study Start Date :
    Jun 27, 2019
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Irccs Policlinico San Donato San Donato Milanese MI Italy 20097

    Sponsors and Collaborators

    • IRCCS Policlinico S. Donato

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mauro Lo Rito, Principal Investigator, IRCCS Policlinico S. Donato
    ClinicalTrials.gov Identifier:
    NCT05692063
    Other Study ID Numbers:
    • AAOCA
    First Posted:
    Jan 20, 2023
    Last Update Posted:
    Jan 25, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 25, 2023