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

NCT03962023 | Recruiting

• 1 other identifier: RC-P0082
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Insufficiency

Keywords

Mitral Valve Insufficiency; Imagery; Prognosis

Outcome Measures

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

  10 years

Study Arms (1)

Patient cohort

Routine follow-up of patients in the Cardiological Functional Explorations department - Valve Disease Centre for their primary mitral insufficiency by prolapse

Other: Echocardiography and MRI

Interventions

Echocardiography and MRI OTHER

Analysis of echocardiography and MRI parameters

Patient cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lille Catholic University: lead
• University Hospital, Lille: collaborator

Study Sites (1)

Lille Catholic Hospitals

Lomme, Nord, 59462, France

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sylvestre Marechaux, Md, PhD

  Lille Catholic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Paule LEBITASY, Md

CONTACT

+33 3 20 22 52 69; lootens.livia@ghicl.net

Audrey TOIA, CRA

CONTACT

+33 3 20 22 57 33; toia.audrey@ghicl.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 23, 2019
• Study Start: September 4, 2019
• Primary Completion (Estimated): September 1, 2034
• Study Completion (Estimated): September 1, 2034
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)