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

Study acronym: COHORTE-IM
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Site contact updatedv6
  2. Minor 2 versions Re-verified since Feb 2, 2021, no change to tracked fieldsv4-v5
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jun 2034 to Sep 2034
    • Start date changed from estimate of Jun 2019 to Sep 4, 2019
    • Site details revised
    v3
  4. Minor Re-verified, no change to tracked fieldsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03962023
Lead Sponsor Lille Catholic University
Collaborators: University Hospital, Lille
Conditions
(from sponsor)
Mitral Valve Insufficiency
Related terms Mitral Valve Insufficiency
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov