European Prospective Registry on Anomalous Aortic Origin of the Coronary Arteries
NCT ID: NCT06089902
Last Updated: 2023-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2019-01-01
2029-01-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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adult > 30 years
All adult patient \> 30 yrs undergoing diagnosis (incidental or not) of anomalous aortic origin of coronary arteries
unroofing or other surgery if needed
unroofing of coronary artery
Juvenile < 30 yrs
All young patient \<30 yrs undergoing diagnosis (incidental or not) of anomalous aortic origin of coronary arteries
unroofing or other surgery if needed
unroofing of coronary artery
Interventions
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unroofing or other surgery if needed
unroofing of coronary artery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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IRCCS Policlinico S. Donato
OTHER
Mitera Children's Hospital, Athens Heart Surgery Institute, Greece
UNKNOWN
Ospedale Civile Ca' Foncello
OTHER
University Hospital, Ghent
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Azienda Ospedaliera Universitaria Integrata Verona
OTHER
University Medical Center Groningen
OTHER
Hospital Universitario La Paz
OTHER
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Azienda Ospedaliero-Universitaria di Parma
OTHER
University of Padova
OTHER
Responsible Party
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PADALINO MASSIMO
Associate Professor
Principal Investigators
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Massimo Padalino, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Padova
Locations
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Massimo Padalino
Padua, PD, Italy
Christopher Grani
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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EUROAAOCA group
Identifier Type: -
Identifier Source: org_study_id
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