Health Data Warehouse on Aortic Insufficiency

Heart Valve Diseases Clinical Trial

— EDS-AI  

Official title:

Setting up a Health Data Warehouse on Aortic Insufficiency

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06420895
• Other study ID #: EDS-2023-02
• Status: Active, not recruiting
• Start date: January 1, 2011
• Est. completion date: December 31, 2033

Study information

• Verified date: May 2024
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (age >= 18 years)

• Cared for at GHICL Since 1st January 2011

• With chronic aortic insufficiency of any grade.

Exclusion Criteria:

• Patients who have undergone prosthetic aortic valve surgery prior to diagnostic transthoracic echocardiography

• Patients with acute heart failure

• Patients with an intracardiac shunt or other complex congenital heart disease or obstructive hypertrophic cardiomyopathy

• Patients with aortic prosthesis

• Patients with active endocarditis or sequelae < 6 months old

• Patients under legal protection

• Patient who refused to take part in the study

• Patients with other than minimal left heart valve disease (with the exception of secondary mitral insufficiency)

Related Conditions & MeSH terms

• Aortic Insufficiency
• Aortic Valve Insufficiency
• Heart Valve Diseases

Intervention

Other:
• Clinical follow-up
Clinical follow-up of patients
• Transthoracic Echocardiogram (TTE)
Transthoracic Echocardiogram
• Magnetic resonance imaging (MRI)
Magnetic resonance imaging
• Transesophageal echocardiogram (TEE)
Transesophageal echocardiogram

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with aortic insufficiency	Whereas this is a data mining process, no description can be provided	one day