NCT03962023 Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM)
| NCT ID | NCT03962023 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lille Catholic University |
| Condition | Mitral Valve Insufficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2019-09-04 |
| Primary Completion | 2034-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2019-09-04 with a primary completion date of 2034-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Sylvestre Marechaux, Md, PhD
PRINCIPAL INVESTIGATOR
Lille Catholic University
Frequently Asked Questions
Who can join the NCT03962023 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Valve Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03962023 currently recruiting?
Yes, NCT03962023 is actively recruiting participants. Contact the research team at lootens.livia@ghicl.net for enrollment information.
Where is the NCT03962023 trial being conducted?
This trial is being conducted at Lomme, France.
Who is sponsoring the NCT03962023 clinical trial?
NCT03962023 is sponsored by Lille Catholic University. The principal investigator is Sylvestre Marechaux, Md, PhD at Lille Catholic University. The trial plans to enroll 400 participants.