Health Data Warehouse on Aortic Insufficiency

Status Active, not recruiting

Clinical Trial 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 l'Institut Catholique de Lille (GHICL) since 2011. The aim is to enable the utilisation of this data for research purposes.

Clinical Trial 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 l'Institut 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 his/her 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 patient's file. There will not be changes in the the patient's 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) - Moderate/medium 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 moderate/medium 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 moderate/undetermined 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06420895
Study type	Observational
Source	Lille Catholic University
Contact
Status	Active, not recruiting
Phase
Start date	January 1, 2011
Completion date	December 31, 2033

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Health Data Warehouse on Aortic Insufficiency — EDS-AI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms