EUROAAOCA: European Prospective Registry on Anomalous Aortic Origin of the Coronary Arteries

Sponsor

University of Padova (Other)

Overall Status

Recruiting

CT.gov ID

NCT06089902

Collaborator

IRCCS Policlinico S. Donato (Other), Mitera Children's Hospital, Athens Heart Surgery Institute, Greece (Other), Ospedale Civile Ca' Foncello (Other), University Hospital, Ghent (Other), Guy's and St Thomas' NHS Foundation Trust (Other), Azienda Ospedaliera Universitaria Integrata Verona (Other), University Medical Center Groningen (Other), Hospital Universitario La Paz (Other), Cliniques universitaires Saint-Luc, Bruxelles, Belgium (Other), Insel Gruppe AG, University Hospital Bern (Other), Azienda Ospedaliero-Universitaria di Parma (Other)

500

Enrollment

Locations

120

Anticipated Duration (Months)

250

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Anomalous aortic origin of a coronary artery (AAOCA) is a group of rare congenital heart defects with various clinical presentations. The lifetime-risk of an individual living with AAOCA is unknown, and data from multicentre registries are urgently needed to adapt current recommendations and guide optimal patient management. The European Registry for AAOCA (EURO-AAOCA) aims to assess differences with regard to AAOCA management between centres.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease Coronary Artery Anomaly Sudden Cardiac Death Surgical Procedure, Unspecified Diagnosis Arrhythmia Heart Defects, Congenital Adult Children	Procedure: unroofing or other surgery if needed

Detailed Description

EURO AAOCA study database on management for "ANOMALOUS AORTIC ORIGIN OF CORONARY ARTERIES.

This is a simple Excel database in 8 sections (see below). The patient's identification (ID) should be anonymous, and can be decided by each center; the investigators suggest to enclose Centre ID number (which is communicated by the leading center) and a sequential number or date of birth (dd/mm/yy).

If no procedure has been done for the patients , it is required to the "PERIPROCEDURAL, SURGICAL DETAILS" and "POSTPROCEDURAL" data sheets (which are outlined in RED). In the "PERIPROCEDURAL" sheet, the participants may refer either to the surgical or non surgical procedure.

Baseline and long term clinical evaluation sections must be completed for all patients.

In the database, there are lists of multiple different variables which are summarized in tables enclosed in the section, in which each item corresponds to a number.

EURO AAOCA Study DATABASE sections

Baseline demo and anatomy: it includes demographic data, and anatomical details for each patient; basic anatomy and course can be selected scrolling an enclosed list; remaining data are requested as yes/no answer
Baseline symptoms and indications: it includes symptoms info and indications to surgical/interventional/clinical follow up for each patient; symptoms can be selected scrolling an enclosed list; remaining data are requested as yes/no answer or text; in particular, the participants are required to distinguish between recreational non-competitive sports (2-3/week) and Competitive (>5 times/week), Reason for diagnosis in asymptomatic patient can be selected scrolling a list.
Baseline instrumental: it includes all possible diagnostic methodologies used for first diagnosis; the test is considered abnormal when it is gives diagnosis of AAOCA, and in this case , the participants are required to describe the findings as precise as possible. In particular, for non-surgical patients, the participants are required to provide a date of the first time any instrumental test suspected AAOCA. ECG data can be selected scrolling an enclosed list; remaining data are requested as yes/no answer or text
Periprocedural: if the patient has gone to surgical or interventional management, the participants are required to fill this section: data can be selected scrolling an enclosed list; remaining data are requested as yes/no answer or text
Surgical details: for surgical patients only, the participants are required to fill this section; data can be selected scrolling an enclosed list; remaining data are requested as yes/no answer or text
Post procedural: for surgical or interventional patients only, the participants are required to fill this section; data can be selected scrolling an enclosed list; remaining data are requested as yes/no answer or text
Follow up 1: this section must be filled for all patients (surgical/interventional /only medical management) and must be updated every year and sent back to the coordinator every June 15th, so as to check yearly the patients. The Investigators suggest an annual follow up for at least 5 years in a row. Follow up data can be selected scrolling an enclosed list; remaining data are requested as yes/no answer or text. T
Follow up Instrumental diagnosis: this section must be filled for all patients (surgical/interventional /only medical management) and must be updated every year and sent back to the coordinator every June 15th, so as to check yearly the patients. The investigators suggest to do this for at least 5 years in a row. Follow up data can be selected scrolling an enclosed list; remaining data are requested as yes/no answer or text

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

EUROAAOCA Registry

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
adult > 30 years All adult patient > 30 yrs undergoing diagnosis (incidental or not) of anomalous aortic origin of coronary arteries	Procedure: unroofing or other surgery if needed unroofing of coronary artery Other Names: clinical follow up
Juvenile < 30 yrs All young patient <30 yrs undergoing diagnosis (incidental or not) of anomalous aortic origin of coronary arteries	Procedure: unroofing or other surgery if needed unroofing of coronary artery Other Names: clinical follow up

Arm

Intervention/Treatment

adult > 30 years

All adult patient > 30 yrs undergoing diagnosis (incidental or not) of anomalous aortic origin of coronary arteries

Procedure: unroofing or other surgery if needed

unroofing of coronary artery

Other Names:

clinical follow up

Juvenile < 30 yrs

All young patient <30 yrs undergoing diagnosis (incidental or not) of anomalous aortic origin of coronary arteries

Procedure: unroofing or other surgery if needed

unroofing of coronary artery

Other Names:

clinical follow up

Outcome Measures

Primary Outcome Measures

Incidence of Symptoms at diagnosis and after surgery [5 years]
The study will assess the presence of symptoms (angina, chest pain, distress, sudden cardiac death-SCD, syncope, aborted SCD) at diagnosis, and after eventual surgical repair, to assess incidence of symptoms in patients with this anomaly and effectiveness of surgery in removing symptoms.
Incidence of postoperative adverse events [5 years]
The study will assess the incidence of operative death and adverse events after surgery (in those who undergo surgery).
Incidence of adverse events at follow up [5 years]
The study will assess the incidence of death and adverse events at clinical follow up either in patients who required a surgical repair or in those who did not undergo surgery because of lack of indications.

Secondary Outcome Measures

Incidence of any arrhythmias at Follow up [5 years]
The study will assess the incidence of any (mostly ventricular) arrhythmias in all patients, either surgical or non surgical
Rate of return to unrestricted competitive sport [5 years]
The study will assess the rate of return to unrestricted sport and competitive sport activity in all patients, either surgical or non surgical

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients with a diagnosis of AAOCA (either referred to surgery or to medical follow-up )

Exclusion Criteria:

isolated high-coronary take-off (≥ 5mm above sino-tubular junction), anomalous origin of a circumflex from the right coronary artery, anomalous course with a normal origin, and association to major congenital heart disease (i.e. Tetralogy of Fallot, transposition of the great arteries, anomalous origin of a coronary from the pulmonary artery).