Anomalous Aortic Origin of Coronary Artery

NCT ID: NCT05692063

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-27

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Anomalous Aortic Origin of the Coronary Artery (AAOCA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Policlinico S. Donato

OTHER

Sponsor Role lead

Responsible Party

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Mauro Lo Rito

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Irccs Policlinico San Donato

San Donato Milanese, MI, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Mauro Lo Rito, MD

Role: primary

+39 0252774849

Other Identifiers

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AAOCA

Identifier Type: -

Identifier Source: org_study_id

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