About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients with a diagnosis of AAOCA (either referred to surgery or to medical follow-up )
Disqualifiers
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).
Trial population
all patients undergoing incidental or not diagnosis of AAOCA
Trial design
Case-only
Prospective
Treatments tested in this trial
unroofing or other surgery if needed
Procedure/Surgeryunroofing of coronary artery
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Symptoms at diagnosis and after surgery
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
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
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 outcomes
Incidence of any arrhythmias at Follow up
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
The study will assess the rate of return to unrestricted sport and competitive sport activity in all patients, either surgical or non surgical
Sponsors and contacts
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University of Padova
Lead sponsor
IRCCS Policlinico S. Donato
Collaborator
Mitera Children's Hospital, Athens Heart Surgery Institute, Greece
Collaborator
Ospedale Civile Ca' Foncello
Collaborator
University Hospital, Ghent
Collaborator
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Azienda Ospedaliera Universitaria Integrata Verona
Collaborator
University Medical Center Groningen
Collaborator
Hospital Universitario La Paz
Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
Azienda Ospedaliero-Universitaria di Parma
Collaborator