Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420895
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-14
Brief Title:
Health Data Warehouse on Aortic Insufficiency
Sponsor:
Lille Catholic University
Organization:
Lille Catholic University
Study Overview
Official Title:
Setting up a Health Data Warehouse on Aortic Insufficiency
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
EDS-AI
Brief Summary:
This project aims to create a data warehouse based on care data of patients with an aortic insufficiency admitted to the Groupement des Hôpitaux de lInstitut Catholique de Lille GHICL since 2011
The aim is to enable the utilisation of this data for research purposes
The aim is to enable the utilisation of this data for research purposes
Detailed Description:
All eligible patients will be informed about the collection of their data during their care at the Valvulopathies Center of Groupement des Hopitaux de lInstitut Catholique de Lille GHICL Their consent will be needed for the inclusion
Data will be collected exclusively by the person responsible for implementing the data processing and hisher authorised staff For all patients data will be collected retrospectively based on medical records electronic or paper and information available on the various care software linked to the patients file There will not be changes in the the patients care
At the GHICL Valvulopathy Centre in accordance with European recommendations patients with aortic insufficiency are monitored as follows depending on the severity of the pathology
Minimal aortic insufficiency follow-up every 3-5 years approximately including clinical examination and transthoracic echocardiogram TTE
Moderatemedium aortic insufficiency follow-up every 1-2 years with clinical examination laboratory tests and TTE
Significant aortic insufficiency follow-up every 6-12 months including a clinical examination a biological assessment and a c- TTE coupled with an exercise test
Cardiac Magnetic Resonance Imaging MRI indicated as a second-line procedure after TTE in cases of moderatemedium aortic insufficiency with arguments or doubts about an underestimation of the severity of the aortic insufficiency on TTE aortic insufficiency of undetermined quantification on TTE or significant aortic insufficiency on TTE to confirm the severity using a multiparametric approach
TEE transesophageal echocardiogram is indicated as 2nd line after TTE in cases of significant aortic insufficiency as part of the preoperative work-up or moderateundetermined aortic insufficiency on TTE
The choice between cardiac MRI or TEE or both as second-line treatment after TEE is left to the clinician in current practice in accordance with the recommendations
Data will be collected exclusively by the person responsible for implementing the data processing and hisher authorised staff For all patients data will be collected retrospectively based on medical records electronic or paper and information available on the various care software linked to the patients file There will not be changes in the the patients care
At the GHICL Valvulopathy Centre in accordance with European recommendations patients with aortic insufficiency are monitored as follows depending on the severity of the pathology
Minimal aortic insufficiency follow-up every 3-5 years approximately including clinical examination and transthoracic echocardiogram TTE
Moderatemedium aortic insufficiency follow-up every 1-2 years with clinical examination laboratory tests and TTE
Significant aortic insufficiency follow-up every 6-12 months including a clinical examination a biological assessment and a c- TTE coupled with an exercise test
Cardiac Magnetic Resonance Imaging MRI indicated as a second-line procedure after TTE in cases of moderatemedium aortic insufficiency with arguments or doubts about an underestimation of the severity of the aortic insufficiency on TTE aortic insufficiency of undetermined quantification on TTE or significant aortic insufficiency on TTE to confirm the severity using a multiparametric approach
TEE transesophageal echocardiogram is indicated as 2nd line after TTE in cases of significant aortic insufficiency as part of the preoperative work-up or moderateundetermined aortic insufficiency on TTE
The choice between cardiac MRI or TEE or both as second-line treatment after TEE is left to the clinician in current practice in accordance with the recommendations
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