Anomalous Aortic Origin of Coronary Artery (AAOCA)

March 5, 2024 updated by: Mauro Lo Rito, IRCCS Policlinico S. Donato

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • San Donato Milanese, MI, Italy, 20097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ischemia, angina event, sudden cardiac death
Time Frame: 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
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
risk factors for ischemia or sudden cardiac deaths
Time Frame: 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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2019

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • AAOCA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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