Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089902
Status:
RECRUITING
Last Update Posted:
2023-10-19
First Post:
2023-10-03
Brief Title:
European Prospective Registry on Anomalous Aortic Origin of the Coronary Arteries
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
Official Title:
EUROAAOCA Registry
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EUROAAOCA
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 patients 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 ddmmyy
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 yesno answer
2 Baseline symptoms and indications it includes symptoms info and indications to surgicalinterventionalclinical follow up for each patient symptoms can be selected scrolling an enclosed list remaining data are requested as yesno answer or text in particular the participants are required to distinguish between recreational non-competitive sports 2-3week and Competitive 5 timesweek 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 yesno 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 yesno 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 yesno 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 yesno answer or text
7 Follow up 1 this section must be filled for all patients surgicalinterventional 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 yesno answer or text T
8 Follow up Instrumental diagnosis this section must be filled for all patients surgicalinterventional 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 yesno answer or text
This is a simple Excel database in 8 sections see below The patients 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 ddmmyy
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 yesno answer
2 Baseline symptoms and indications it includes symptoms info and indications to surgicalinterventionalclinical follow up for each patient symptoms can be selected scrolling an enclosed list remaining data are requested as yesno answer or text in particular the participants are required to distinguish between recreational non-competitive sports 2-3week and Competitive 5 timesweek 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 yesno 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 yesno 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 yesno 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 yesno answer or text
7 Follow up 1 this section must be filled for all patients surgicalinterventional 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 yesno answer or text T
8 Follow up Instrumental diagnosis this section must be filled for all patients surgicalinterventional 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 yesno answer or text
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None