Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLille Catholic University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Secondary MI

Primary MI without valve prolapse

Active endocarditis

Patient's refusal to participate in the study

Trial 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)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Echocardiography and MRI

    Other intervention

    Analysis of echocardiography and MRI parameters

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Patient cohort1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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Lille Catholic University

Lead sponsor

University Hospital, Lille

Collaborator