Aortic InsufficiencyEDS-AINCT06420895
Health Data Warehouse on Aortic Insufficiency
An observational study of Aortic Insufficiency and Heart Valve Diseases, run by Lille Catholic University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Insufficiency, Heart Valve Diseases
- What is being tested?
- Clinical follow-up, Transthoracic Echocardiogram (TTE) and Magnetic resonance imaging (MRI)
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- Adult patients (age >= 18 years)
- Cared for at GHICL Since 1st January 2011
- With chronic aortic insufficiency of any grade.
Who cannot join
- 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)
About this study
Official title: 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.
Read the 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
- Aortic Insufficiency, Heart Valve Diseases
- Being tested
- Clinical follow-up, Transthoracic Echocardiogram (TTE), Magnetic resonance imaging (MRI), Transesophageal echocardiogram (TEE)
- Keywords
- aortic insufficiency, valvulopathy, Transthoracic echocardiogram, ultrasound, transesophageal echocardiogram, Data Warehouse
- Medical subject headings
- Aortic Valve Insufficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical follow-upOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical follow-up; Other: Transthoracic Echocardiogram (TTE); Other: Magnetic resonance imaging (MRI); Other: Transesophageal echocardiogram (TEE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with aortic insufficiency
Whereas this is a data mining process, no description can be provided
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Jan 2011
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Altes, MD, Principal investigator, altes.alexandre@ghicl.net
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420895
- Sponsor's protocol ID
- EDS-2023-02
- Acronym
- EDS-AI
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Setting up a Health Data Warehouse on Aortic Insufficiency
- ClinicalTrials.gov ID
- NCT06420895
- Acronym / sponsor ID
- EDS-AI / EDS-2023-02
- Conditions
- Aortic Insufficiency, Heart Valve Diseases
- Keywords
- aortic insufficiency, valvulopathy, Transthoracic echocardiogram, ultrasound, transesophageal echocardiogram, Data Warehouse
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group of patients with aortic insufficiency | – | Other: Clinical follow-up, Other: Transthoracic Echocardiogram (TTE), Other: Magnetic resonance imaging (MRI), Other: Transesophageal echocardiogram (TEE)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Adult patients (age >= 18 years)
- Cared for at GHICL Since 1st January 2011
- With chronic aortic insufficiency of any grade.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical follow-upClinical follow-up of patients | Other | Group of patients with aortic insufficiency |
| Transthoracic Echocardiogram (TTE)Transthoracic Echocardiogram | Other | Group of patients with aortic insufficiency |
| Magnetic resonance imaging (MRI)Magnetic resonance imaging | Other | Group of patients with aortic insufficiency |
| Transesophageal echocardiogram (TEE)Transesophageal echocardiogram | Other | Group of patients with aortic insufficiency |
Primary outcome
Number of patients with aortic insufficiency
Time frame: one day
Whereas this is a data mining process, no description can be provided
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Aortic Insufficiency
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Active, not recruiting
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Active, not recruiting
The JenaValve ALIGN-AR LVAD Registry
Aortic Regurgitation, Aortic Valve Insufficiency
Active, not recruiting
J-Valve Transfemoral Pivotal Study
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Altes, MD principal investigator
altes.alexandre@ghicl.net
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Insufficiency and Heart Valve Diseases, run by Lille Catholic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with aortic insufficiency (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.