Health Data Warehouse on Aortic Insufficiency (EDS-AI)

Setting up a Health Data Warehouse on Aortic Insufficiency

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Valve Diseases; Aortic Insufficiency
• Intervention / Treatment: Other: Clinical follow-up; Other: Transthoracic Echocardiogram (TTE); Other: Magnetic resonance imaging (MRI); Other: Transesophageal echocardiogram (TEE)

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 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 Type: Observational
• Enrollment (Estimated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients already assessed at GHICL's Valvulopathy Centre from 2011 to October 2023 will be identified retrospectively, by queries based on keywords and/or diagnostic codes in echocardiography interpretation software (Viewpoint/EchoPAC, ISCV). GHICL's Medical Information Department (DIM) will also be involved.

Eligible patients assessed at GHICL's Valvulopathy Centre after the implementation of the repository (from November 2023) will be identified by the cardiologist as and when required.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group of patients with aortic insufficiency; Patients already assessed at GHICL's Valvulopathy Centre from 2011 to October 2023 will be identified retrospectively, by queries based on keywords and/or diagnostic codes in echocardiography interpretation software (Viewpoint/EchoPAC, ISCV). GHICL's Medical Information Department will also be involved.	Other: Clinical follow-up; Clinical follow-up of patients; Other: Transthoracic Echocardiogram (TTE); Transthoracic Echocardiogram; Other: Magnetic resonance imaging (MRI); Magnetic resonance imaging; Other: Transesophageal echocardiogram (TEE); Transesophageal echocardiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with aortic insufficiency	Whereas this is a data mining process, no description can be provided	one day

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Alexandre Altes, MD, altes.alexandre@ghicl.net

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; transesophageal echocardiogram; Transthoracic echocardiogram; aortic insufficiency; valvulopathy; Data Warehouse
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Aortic Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: EDS-2023-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No