## Protocol Section
### Identification Module
**NCT ID:** NCT06420895

**Acronym:** EDS-AI

**Brief Title:** Health Data Warehouse on Aortic Insufficiency

**Official Title:** Setting up a Health Data Warehouse on Aortic Insufficiency

#### Organization Study ID Info
**ID:** EDS-2023-02
#### Organization
**Class:** OTHER
**Full Name:** Lille Catholic University
### Status Module
#### Completion Date
**Date:** 2033-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2028-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2011-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Lille Catholic University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 l'Institut Catholique de Lille (GHICL) since 2011.

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 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.

### Conditions Module

**Conditions:**

- Aortic Insufficiency

- Heart Valve Diseases

**Keywords:**

- aortic insufficiency

- valvulopathy

- Transthoracic echocardiogram

- ultrasound

- transesophageal echocardiogram

- Data Warehouse

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Clinical follow-up

- Other: Transthoracic Echocardiogram (TTE)

- Other: Magnetic resonance imaging (MRI)

- Other: Transesophageal echocardiogram (TEE)

**Label:** Group of patients with aortic insufficiency

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group of patients with aortic insufficiency

**Description:** Clinical follow-up of patients

**Name:** Clinical follow-up

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Group of patients with aortic insufficiency

**Description:** Transthoracic Echocardiogram

**Name:** Transthoracic Echocardiogram (TTE)

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Group of patients with aortic insufficiency

**Description:** Magnetic resonance imaging

**Name:** Magnetic resonance imaging (MRI)

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Group of patients with aortic insufficiency

**Description:** Transesophageal echocardiogram

**Name:** Transesophageal echocardiogram (TEE)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Whereas this is a data mining process, no description can be provided

**Measure:** Number of patients with aortic insufficiency

**Time Frame:** one day

### Eligibility Module

**Eligibility Criteria:** 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)

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** altes.alexandre@ghicl.net

**Name:** Alexandre Altes, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000082862

- Term: Aortic Valve Disease

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9437

- Name: Heart Valve Diseases

- Relevance: HIGH

- As Found: Heart Valve Diseases

- ID: M4338

- Name: Aortic Valve Insufficiency

- Relevance: HIGH

- As Found: Aortic Insufficiency

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2379

- Name: Aortic Valve Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006349

- Term: Heart Valve Diseases

- ID: D000001022

- Term: Aortic Valve Insufficiency

### Misc Info Module

- Version Holder: 2024-05-31
