Clinical trial NCT03962023: Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Valve Insufficiency
Keywords: Mitral Valve Insufficiency
Imagery
Prognosis
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
First posted: 2019-05-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Secondary MI
* Primary MI without valve prolapse
* Active endocarditis
* Patient's refusal to participate in the study
* Patient under guardianship or curatorship

Primary outcomes:
measure: Time before the first morbi-mortality event
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lomme
country: France
facility: Lille Catholic Hospitals
state: Nord
Study officials:
affiliation: Lille Catholic University
name: Sylvestre Marechaux, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: