European Prospective Registry on Anomalous Aortic Origin of the Coronary Arteries

Congenital Heart Disease Clinical Trial

— EUROAAOCA  

Official title:

EUROAAOCA Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06089902
• Other study ID #: EUROAAOCA group
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: January 1, 2029

Study information

• Verified date: October 2023
• Source: University of Padova
• Contact: Massimo Padalino, MD PhD
• Phone: 00393408922564
• Email: massimo.padalino[@]unipd.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Adult Children
• Arrhythmia
• Congenital Abnormalities
• Congenital Heart Disease
• Coronary Artery Anomaly
• Death
• Death, Sudden, Cardiac
• Diagnosis
• Heart Defects, Congenital
• Heart Diseases
• Sudden Cardiac Death
• Surgical Procedure, Unspecified

Intervention

Procedure:
• unroofing or other surgery if needed
unroofing of coronary artery

Locations

Country	Name	City	State
Italy	Massimo Padalino	Padova	PD
Switzerland	Christopher Grani	Bern

Sponsors (12)

Lead Sponsor

Collaborator

University of Padova

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

Countries where clinical trial is conducted

Italy,  Switzerland, 

References & Publications (6)

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 A — View 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. — View 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, Sarri — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years
Primary	Incidence of postoperative adverse events	The study will assess the incidence of operative death and adverse events after surgery (in those who undergo surgery).	5 years
Primary	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.	5 years
Secondary	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	5 years
Secondary	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	5 years