European Prospective Registry on Anomalous Aortic Origin of the Coronary Arteries

NCT06089902 | Recruiting

• 1 other identifier: EUROAAOCA group
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Incidence of any arrhythmias at Follow up

  5 years

• Rate of return to unrestricted competitive sport

  5 years

Study Arms (2)

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

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

Interventions

unroofing or other surgery if needed PROCEDURE

unroofing of coronary artery

Also known as: clinical follow up

Juvenile < 30 yrs; adult > 30 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients undergoing incidental or not diagnosis of AAOCA

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Padova: lead
• 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

Study Sites (2)

Massimo Padalino

Padua, PD, 35128, Italy

RECRUITING

Christopher Grani

Bern, Switzerland

RECRUITING

Related Publications (6)

• 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.

  PMID: 34055925 RESULT

• 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.

  PMID: 36205254 RESULT

• 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.

  PMID: 35757950 RESULT

• 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.

  PMID: 35224033 RESULT

• 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.

  PMID: 34136540 RESULT

• 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.

  PMID: 30897195 RESULT

MeSH Terms

Conditions

Heart Defects, Congenital; Death, Sudden, Cardiac; Disease; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Padalino, MD PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Padalino, MD PhD

CONTACT

00393408922564; massimo.padalino@unipd.it

Chris Grani, MD PhD

CONTACT

0041788158858; christoph.graeni@insel.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 19, 2023
• Study Start: January 1, 2019
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); CH (1)