Clinical trial NCT06089902: European Prospective Registry on Anomalous Aortic Origin of the Coronary Arteries
Official title: EUROAAOCA Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Heart Disease
Coronary Artery Anomaly
Sudden Cardiac Death
Surgical Procedure, Unspecified
Diagnosis
Arrhythmia
Heart Defects, Congenital
Adult Children
Keywords: anomalous
coronary
sudden cardiac death
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: IRCCS Policlinico S. Donato
name: Mitera Children's Hospital, Athens Heart Surgery Institute, Greece
name: Ospedale Civile Ca' Foncello
name: University Hospital, Ghent
name: Guy's and St Thomas' NHS Foundation Trust
name: Azienda Ospedaliera Universitaria Integrata Verona
name: University Medical Center Groningen
name: Hospital Universitario La Paz
name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Insel Gruppe AG, University Hospital Bern
name: Azienda Ospedaliero-Universitaria di Parma
First posted: 2023-10-19
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients undergoing incidental or not diagnosis of AAOCA

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.

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

1. 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
2. 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.
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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

Eligibility criteria: 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).

Primary outcomes:
measure: Incidence of Symptoms at diagnosis and after surgery
timeFrame: 5 years
measure: Incidence of postoperative adverse events
timeFrame: 5 years
measure: Incidence of adverse events at follow up
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of any arrhythmias at Follow up
timeFrame: 5 years
measure: Rate of return to unrestricted competitive sport
timeFrame: 5 years
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Massimo Padalino
state: PD
city: Bern
country: Switzerland
facility: Christopher Grani
Study officials:
affiliation: University of Padova
name: Massimo Padalino, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Padalino MA, Jegatheeswaran A, Blitzer D, Ricciardi G, Guariento A. Surgery for Anomalous Aortic Origin of Coronary Arteries: Technical Safeguards and Pitfalls. Front Cardiovasc Med. 2021 May 12;8:626108. doi: 10.3389/fcvm.2021.626108. eCollection 2021.
citation: Bigler MR, Kadner A, Raber L, Ashraf A, Windecker S, Siepe M, Padalino MA, Grani C. Therapeutic Management of Anomalous Coronary Arteries Originating From the Opposite Sinus of Valsalva: Current Evidence, Proposed Approach, and the Unknowing. J Am Heart Assoc. 2022 Oct 18;11(20):e027098. doi: 10.1161/JAHA.122.027098. Epub 2022 Oct 7.
citation: Ponzoni M, Frigo AC, Padalino MA. Surgery for Anomalous Aortic Origin of a Coronary Artery (AAOCA) in Children and Adolescents: A Meta-Analysis. World J Pediatr Congenit Heart Surg. 2022 Jul;13(4):485-494. doi: 10.1177/21501351221095424.
citation: Grani C, Padalino MA. Editorial: Coronary Artery Anomalies: A 2020 Review. Front Cardiovasc Med. 2022 Feb 10;9:776951. doi: 10.3389/fcvm.2022.776951. eCollection 2022. No abstract available.
citation: Thiene G, Frescura C, Padalino M, Basso C, Rizzo S. Coronary Arteries: Normal Anatomy With Historical Notes and Embryology of Main Stems. Front Cardiovasc Med. 2021 May 31;8:649855. doi: 10.3389/fcvm.2021.649855. eCollection 2021.
citation: Padalino MA, Franchetti N, Hazekamp M, Sojak V, Carrel T, Frigiola A, Lo Rito M, Horer J, Roussin R, Cleuziou J, Meyns B, Fragata J, Telles H, Polimenakos AC, Francois K, Veshti A, Salminen J, Rocafort AG, Nosal M, Vedovelli L, Guariento A, Vida VL, Sarris GE, Boccuzzo G, Stellin G. Surgery for anomalous aortic origin of coronary arteries: a multicentre study from the European Congenital Heart Surgeons Associationdagger. Eur J Cardiothorac Surg. 2019 Oct 1;56(4):696-703. doi: 10.1093/ejcts/ezz080.