Anomalous Aortic Origin of the Coronary Artery (AAOCA)AAOCANCT05692063
Anomalous Aortic Origin of Coronary Artery
An observational study of Anomalous Aortic Origin of the Coronary Artery (AAOCA), run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anomalous Aortic Origin of the Coronary Artery (AAOCA)
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jun 2019to 31 Jul 2037
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients (adults and pediatrics) with diagnosis of anomalous aortic origin of coronary arteries
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Irccs Policlinico San Donato
San Donato Milanese, MI, 20097
Mauro Lo Rito, MD, +39 0252774849, Mauro.lorito@grupposandonato.it
About this study
Official title: 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:
- Clinical objectives:
- 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.
- 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).
- Experimental objectives:
- Retrieve morphological measurements from CT or MRI (de-identified) of the aortic root and the coronary vessels following the previous work of our group.
- Construct a parametric model of the aortic root defined by population-based morphologic parameters to describe both healthy/diseased population.
- Run solid mechanics simulation mimicking the movement of the aortic root in order to test configurations at more risk.
- Reconstruct 3D surfaces representing the coronary vasculature from imaging for automatically perform the parameter estimation and run computational fluid dynamics simulations.
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemia, angina event, sudden cardiac death
- 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
Measured: 10 years
Secondary outcomes (1)
risk factors for ischemia or sudden cardiac deaths
- 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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start27 Jun 2019
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anomalous Aortic Origin of the Coronary Artery (AAOCA)Studies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Lo Rito, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692063
- Sponsor's protocol ID
- AAOCA
- Acronym
- AAOCA
- Status last verified
- Jul 2026
- First submitted
- 11 Jan 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anomalous Aortic Origin of Coronary Artery: From Pathophysiology to Risk Stratification Through a Patient Specific Computational Simulation Model
- ClinicalTrials.gov ID
- NCT05692063
- Acronym / sponsor ID
- AAOCA / AAOCA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2037 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project has several objectives ranging from clinical data analysis to computational simulations as listed below:
- Clinical objectives:
- 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.
- 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).
- Experimental objectives:
- Retrieve morphological measurements from CT or MRI (de-identified) of the aortic root and the coronary vessels following the previous work of our group.
- Construct a parametric model of the aortic root defined by population-based morphologic parameters to describe both healthy/diseased population.
- Run solid mechanics simulation mimicking the movement of the aortic root in order to test configurations at more risk.
- Reconstruct 3D surfaces representing the coronary vasculature from imaging for automatically perform the parameter estimation and run computational fluid dynamics simulations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients (adults and pediatrics) with diagnosis of anomalous aortic origin of coronary arteries
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
risk factors for ischemia or sudden cardiac deaths
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Recruiting
Speed-up the Diagnosis and Evaluation of anoMalous Coronary ARTery From the Aorta
AAOCA, ACAOS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anomalous Aortic Origin of the Coronary Artery (AAOCA), run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischemia, angina event, sudden cardiac death (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.