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Active, Not Recruiting

NCT Number: NCT06420895

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Clinical follow-up

Other

Clinical follow-up of patients

Transthoracic echocardiogram (TTE)

Other

Transthoracic Echocardiogram

magnetic resonance imaging (MRI)

Other

Magnetic resonance imaging

Transesophageal echocardiogram (TEE)

Other

Transesophageal echocardiogram

Primary outcomes

  1. Number of patients with aortic insufficiency

    Time frame: one day

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

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

Setting up a Health Data Warehouse on Aortic Insufficiency

Acronym: EDS-AI

Important dates

Study start
2011
Primary completion
2028
Study completion
2033
First posted
May 20, 2024
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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