NCT06420895

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
93mo left

Started Jan 2011

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2011Dec 2033

Study Start

First participant enrolled

January 1, 2011

Completed
13.4 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

18 years

First QC Date

May 14, 2024

Last Update Submit

May 14, 2024

Conditions

Aortic InsufficiencyHeart Valve Diseases

Keywords

aortic insufficiencyvalvulopathyTransthoracic echocardiogramultrasoundtransesophageal echocardiogramData Warehouse

Outcome Measures

Primary Outcomes (1)

  • Number of patients with aortic insufficiency

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

    one day

Study Arms (1)

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-upOther: Transthoracic Echocardiogram (TTE)Other: Magnetic resonance imaging (MRI)Other: Transesophageal echocardiogram (TEE)

Interventions

Clinical follow-upOTHER

Clinical follow-up of patients

Group of patients with aortic insufficiency
Transthoracic Echocardiogram (TTE)OTHER

Transthoracic Echocardiogram

Group of patients with aortic insufficiency
Magnetic resonance imaging (MRI)OTHER

Magnetic resonance imaging

Group of patients with aortic insufficiency
Transesophageal echocardiogram (TEE)OTHER

Transesophageal echocardiogram

Group of patients with aortic insufficiency

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Adult patients (age \>= 18 years)
  • Cared for at GHICL Since 1st January 2011
  • With chronic aortic insufficiency of any grade.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve InsufficiencyHeart Valve Diseases

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Alexandre Altes, MD

    altes.alexandre@ghicl.net

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 20, 2024

Study Start

January 1, 2011

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2033

Last Updated

May 20, 2024

Record last verified: 2024-05