European Prospective Registry on Anomalous Aortic Origin of the Coronary Arteries

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Padova

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • unroofing or other surgery if needed

    Procedure/Surgery

    unroofing of coronary artery

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: adult > 30 years1 intervention
Group B: Juvenile < 30 yrs1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years
2

Incidence of postoperative adverse events

The study will assess the incidence of operative death and adverse events after surgery (in those who undergo surgery).

Time frame
5 years
3

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.

Time frame
5 years

Secondary outcomes

1

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

Time frame
5 years
2

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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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