Evaluating imaging parameters in patients with mitral valve insufficiency due to prolapse
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)
Run by Lille Catholic University · NCT03962023 · Data updated 2026-11-12
This study is testing how different imaging techniques can help doctors better understand and treat patients with mitral valve problems caused by prolapse.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Lille Catholic University Academic / other |
| Locations | 1 site (Lomme, Nord) |
| Status | Recruiting |
| Started | September 4, 2019 |
| Main results expected | September 2034 |
| Study ends | September 2034 |
| Registry record updated | March 26, 2024 |
| Trial ID | NCT03962023 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults diagnosed with primary mitral insufficiency due to valve prolapse, regardless of the severity of their condition.
✕Probably not a fit
Patients with secondary mitral insufficiency or those who have undergone previous mitral valve surgery will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the prognostic impact of various imaging parameters in patients suffering from primary mitral insufficiency caused by valve prolapse. It will follow a cohort of patients diagnosed with this condition to analyze the relationships between echocardiographic and MRI findings and patient outcomes. The goal is to refine risk stratification, identifying those who may benefit from earlier surgical intervention or require close monitoring. The study will utilize advanced imaging techniques to evaluate cardiac function and size more accurately than traditional methods.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with mitral valve insufficiency, potentially reducing morbidity and mortality.
How similar studies have gone: While there have been studies on mitral valve insufficiency, this specific approach using advanced imaging techniques for prognostic evaluation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Lille Catholic Hospitals
Lomme, Nord, France Recruiting
Study contacts
- Principal investigator: Sylvestre Marechaux, Md, PhD — Lille Catholic University
- Study coordinator: Marie Paule LEBITASY, Md
- Email: lootens.livia@ghicl.net
- Phone: +33 3 20 22 52 69
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.