Mitral Valve InsufficiencyCOHORTE-IMNCT03962023
Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM)
An observational study of Mitral Valve Insufficiency, run by Lille Catholic University at 1 site in France.
Trial summary
Degenerative mitral insufficiency secondary to valve prolapse is the most common valve disease in Western countries. In the absence of specific treatment, it spontaneously progresses to heart failure and death when it is severe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- Echocardiography and MRI
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2019to Sep 2034
- How long will I take part?
- 10 Years
- 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
- Adult, Older adult
Study population: Patients with primary mitral insufficiency by prolapse, who came or will come to the echocardiography laboratory of Saint Philibert Hospital for a Trans-Thoracic Echocardiography (TTE)
Who may be able to join
- Any patient with primary mitral insufficiency by prolapse (any grade) diagnosed by Trans-Thoracic Echocardiography (TTE)
- From November 2010 to April 2019 (retrospective cohort)
- From May 2019 to May 2024 (prospective cohort)
- No previous surgery of the mitral valve before the first ultrasound
- Adults
- Patient who has been informed and not opposed to the use of his or her medical record data
Who cannot join
- Secondary MI
- Primary MI without valve prolapse
- Active endocarditis
- Patient's refusal to participate in the study
- Patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Lille Catholic Hospitals
Lomme, Nord, 59462
Marie Paule LEBITASY, Md, +33 3 20 22 52 69 ext. +33, lootens.livia@ghicl.net
Audrey Toia, CRA, +33 3 20 22 57 33 ext. +33, toia.audrey@ghicl.net
About this study
Official title: Prognostic Impact of Non-invasive Imaging Parameters (Cardiac Echocardiography and MRI) in Patients With Primary Mitral Insufficiency (MI) by Prolapse: Observational Cohort, Monocentric (COHORTE-IM)
Degenerative mitral insufficiency secondary to valve prolapse is the most common valve disease in Western countries. In the absence of specific treatment, it spontaneously progresses to heart failure and death when it is severe. Surgical mitral valve repair (or mitral plastic surgery) is the preferred treatment for primary mitral insufficiency by prolapse in case of severe leakage if associated with clinical and/or echocardiographic markers of poor prognosis (i.e., with high risk of morbi-mortality during their follow-up).
It is therefore essential to refine the risk stratification of these patients in order to identify at-risk patients who should potentially benefit earlier from invasive care (cardiac surgery), or conversely, close monitoring.
Read more
A number of echocardiographic and MRI parameters may have been associated with a poorer prognosis.
A cohort of patients with primary mitral insufficiency (MI) will be followed to study the relationships of a set of factors to patient prognosis.
Read the detailed description
Degenerative mitral insufficiency secondary to valve prolapse is the most common valve disease in Western countries. In the absence of specific treatment, it spontaneously progresses to heart failure and death when it is severe. Surgical mitral valve repair (or mitral plastic surgery) is the preferred treatment for primary mitral insufficiency by prolapse in case of severe leakage if associated with clinical and/or echocardiographic markers of poor prognosis (i.e., at high risk of morbi-mortality during their follow-up).
It is therefore essential to refine the risk stratification of these patients in order to identify at-risk patients who should potentially benefit earlier from invasive care (cardiac surgery), or conversely, close monitoring.
Beyond the regurgitation severity parameters, a number of regurgitation resonance parameters may have been associated with a poorer prognosis. These parameters include dilation of the left ventricle (increase of telesystolic diameter), of the left atrium, decrease of left ventricular ejection fraction (FE VG), and increase of pulmonary pressures (pulmonary hypertension). The relationship between left, right ventricular function, atrial function evaluated by new echocardiographic techniques (Speckle tracking, 3D) and prognosis has been poorly studied.
These new innovative techniques are now available in clinical routine and allow an evaluation of size and cardiac function parameters in a more reproducible way than conventional methods. The relationship between prognosis and the assessment of regurgitation severity by the convergence zone method (PISA method) has been well documented in the literature. However, the PISA method presents well-documented reproducibility problems. Other methods of quantification exist, either by echocardiography (qualitative, semi-quantitative and quantitative methods) or by MRI (quantitative methods). They are useful in clinical practice in a multiparametric approach, but their relationship to prognosis has been not well studied.
Thus, the prognostic impact of the following parameters must be studied:
- Echocardiographic and MRI parameters of primary insufficiency severity and their combination
- Ventricular and atrial functions measured by innovative echocardiographic methods (speckle tracking, 3D, left ventricular ejection performance parameters)
- The remodeling of cardiac cavities related to mitral insufficiency evaluated by echocardiography and MRI, apart from the diameter of the left ventricle and the size of the left atrium that has already been studied.
A cohort of patients with primary mitral insufficiency (MI) will be followed up to study the relationships of all these factors with patient prognosis. Part of this cohort will be retrospective, and part will be prospective.
- Conditions
- Mitral Valve Insufficiency
- Being tested
- Echocardiography and MRI
- Keywords
- Mitral Valve Insufficiency, Imagery, Prognosis
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography and MRIOther
Analysis of echocardiography and MRI parameters
| Study group | Role | What they receive |
|---|---|---|
| Patient cohort | Routine follow-up of patients in the Cardiological Functional Explorations department - Valve Disease Centre for their primary mitral insufficiency by prolapse Receives: Other: Echocardiography and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time before the first morbi-mortality event
The impact of different parameters obtained by Doppler echocardiography (two-dimensional or three-dimensional mode) or MRI on the prognosis of time of the first morbi-mortality event arrival will be studied.
Morbi-mortality is defined as the occurrence of at least one of the following events during follow-up:
- Death from any cause
- Cardiovascular death defined as linked to heart failure, myocardial infarction, arrhythmia episode and sudden death
- Hospitalization for heart failure
- Occurrence of atrial fibrillation
- Occurrence of a stroke
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start4 Sep 2019
- Primary completionSep 2034 (estimated)
- Study completionSep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve 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
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Sylvestre Marechaux, Md, PhD, Principal investigator, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962023
- Sponsor's protocol ID
- RC-P0082
- Acronym
- COHORTE-IM
- Status last verified
- Mar 2024
- First submitted
- 22 May 2019
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Non-invasive Imaging Parameters (Cardiac Echocardiography and MRI) in Patients With Primary Mitral Insufficiency (MI) by Prolapse: Observational Cohort, Monocentric (COHORTE-IM)
- ClinicalTrials.gov ID
- NCT03962023
- Acronym / sponsor ID
- COHORTE-IM / RC-P0082
- Conditions
- Mitral Valve Insufficiency
- Keywords
- Mitral Valve Insufficiency, Imagery, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- Sep 2034 (estimated)
- Study completion
- Sep 2034 (estimated)
- First posted
- 23 May 2019 (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.
Degenerative mitral insufficiency secondary to valve prolapse is the most common valve disease in Western countries. In the absence of specific treatment, it spontaneously progresses to heart failure and death when it is severe. Surgical mitral valve repair (or mitral plastic surgery) is the preferred treatment for primary mitral insufficiency by prolapse in case of severe leakage if associated with clinical and/or echocardiographic markers of poor prognosis (i.e., with high risk of morbi-mortality during their follow-up).
It is therefore essential to refine the risk stratification of these patients in order to identify at-risk patients who should potentially benefit earlier from invasive care (cardiac surgery), or conversely, close monitoring.
A number of echocardiographic and MRI parameters may have been associated with a poorer prognosis.
A cohort of patients with primary mitral insufficiency (MI) will be followed to study the relationships of a set of factors to patient prognosis.
Detailed description
Degenerative mitral insufficiency secondary to valve prolapse is the most common valve disease in Western countries. In the absence of specific treatment, it spontaneously progresses to heart failure and death when it is severe. Surgical mitral valve repair (or mitral plastic surgery) is the preferred treatment for primary mitral insufficiency by prolapse in case of severe leakage if associated with clinical and/or echocardiographic markers of poor prognosis (i.e., at high risk of morbi-mortality during their follow-up).
It is therefore essential to refine the risk stratification of these patients in order to identify at-risk patients who should potentially benefit earlier from invasive care (cardiac surgery), or conversely, close monitoring.
Beyond the regurgitation severity parameters, a number of regurgitation resonance parameters may have been associated with a poorer prognosis. These parameters include dilation of the left ventricle (increase of telesystolic diameter), of the left atrium, decrease of left ventricular ejection fraction (FE VG), and increase of pulmonary pressures (pulmonary hypertension). The relationship between left, right ventricular function, atrial function evaluated by new echocardiographic techniques (Speckle tracking, 3D) and prognosis has been poorly studied.
These new innovative techniques are now available in clinical routine and allow an evaluation of size and cardiac function parameters in a more reproducible way than conventional methods. The relationship between prognosis and the assessment of regurgitation severity by the convergence zone method (PISA method) has been well documented in the literature. However, the PISA method presents well-documented reproducibility problems. Other methods of quantification exist, either by echocardiography (qualitative, semi-quantitative and quantitative methods) or by MRI (quantitative methods). They are useful in clinical practice in a multiparametric approach, but their relationship to prognosis has been not well studied.
Thus, the prognostic impact of the following parameters must be studied:
- Echocardiographic and MRI parameters of primary insufficiency severity and their combination
- Ventricular and atrial functions measured by innovative echocardiographic methods (speckle tracking, 3D, left ventricular ejection performance parameters)
- The remodeling of cardiac cavities related to mitral insufficiency evaluated by echocardiography and MRI, apart from the diameter of the left ventricle and the size of the left atrium that has already been studied.
A cohort of patients with primary mitral insufficiency (MI) will be followed up to study the relationships of all these factors with patient prognosis. Part of this cohort will be retrospective, and part will be prospective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient cohort | – | Other: Echocardiography and MRIRoutine follow-up of patients in the Cardiological Functional Explorations department - Valve Disease Centre for their primary mitral insufficiency by prolapse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with primary mitral insufficiency by prolapse, who came or will come to the echocardiography laboratory of Saint Philibert Hospital for a Trans-Thoracic Echocardiography (TTE)
Key inclusion criteria (6 listed)
- Any patient with primary mitral insufficiency by prolapse (any grade) diagnosed by Trans-Thoracic Echocardiography (TTE)
- From November 2010 to April 2019 (retrospective cohort)
- From May 2019 to May 2024 (prospective cohort)
- No previous surgery of the mitral valve before the first ultrasound
- Adults
Key exclusion criteria (5 listed)
- Secondary MI
- Primary MI without valve prolapse
- Active endocarditis
- Patient's refusal to participate in the study
- Patient under guardianship or curatorship
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 |
|---|---|---|
| Echocardiography and MRIAnalysis of echocardiography and MRI parameters | Other | Patient cohort |
Primary outcome
Time before the first morbi-mortality event
Time frame: 10 years
The impact of different parameters obtained by Doppler echocardiography (two-dimensional or three-dimensional mode) or MRI on the prognosis of time of the first morbi-mortality event arrival will be studied. Morbi-mortality is defined as the occurrence of at least one of the following events during follow-up: * Death from any cause * Cardiovascular death defined as linked to heart failure, myocardial infarction, arrhythmia episode and sudden death * Hospitalization for heart failure * Occurrence of atrial fibrillation * Occurrence of a stroke
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 26 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Sylvestre Marechaux, Md, PhD principal investigator
Lille Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Insufficiency, run by Lille Catholic University at 1 site in France.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Marie Paule LEBITASY, Md (+33 3 20 22 52 69 ext. +33, lootens.livia@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time before the first morbi-mortality event (time frame: 10 years). 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 26 Mar 2024.