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Recruiting NCT06089902

European Prospective Registry on Anomalous Aortic Origin of the Coronary Arteries

Observational Congenital Heart Disease Coronary Artery Anomaly Sudden Cardiac Death Surgical Procedure, Unspecified

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: unroofing or other surgery if needed.
Who it may be relevant to
Registry conditions: Congenital Heart Disease, Coronary Artery Anomaly, Sudden Cardiac Death, Surgical Procedure, Unspecified. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

EUROAAOCA Registry

Overview

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

Interventions

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

Primary outcome measures

  • Incidence of Symptoms at diagnosis and after surgery [Time frame: 5 years]
  • Incidence of postoperative adverse events [Time frame: 5 years]
  • Incidence of adverse events at follow up [Time frame: 5 years]
Secondary outcome measures (2)
  • Incidence of any arrhythmias at Follow up [Time frame: 5 years]
  • Rate of return to unrestricted competitive sport [Time frame: 5 years]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Italy · 1 center
  • Massimo Padalino — Padova
Switzerland · 1 center
  • Christopher Grani — Bern

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 Sur PMID 30897195

Identifiers

NCT: NCT06089902 · EUROAAOCA group

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗