Quantification of Mitral Regurgitation Using 4D MRI Flow : Comparison With 2D MRI Flow and Echocardiography Using the Evolution of Left Ventricular Remodeling as a Reference

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The goal of this study is to evaluate whether 4D MRI provides a better assessment of mitral regurgitation quantification and associated ventricular remodeling than standard imaging techniques: echocardiography and 2D MRI, in patients suffuring from mitral regurgitation. 4D MRI demonstrated its superiority to 2D MRI in some other valve diseases but remains not widely used, due to a lack of evidence. The main question our study aims to answer is:

• Is mitral regurgitant volume measured on 4D MRI more strongly related to remodeling progression (after correction of regurgitation or not) than regurgitant volume measured on 2D MRI and echocardiography?

Participants will undergo 4D MRI, 2D MRI and echocardiography twice at six-month intervals.

Eligibility criteria

Qualifiers

from 18 to 85 years old

having signed a consent form to participate in the study

suffering from mild, moderate or severe mitral regurgitation based on an ultrasound graduation

able to undergo echocardiography and IRM within 7 days after recruitment and then at 6 months

Disqualifiers

suffering from aortic regurgitation or stenosis or mitral stenosis associated with more than moderate MR, intracardiac shunting or hypertrophic cardiomyopathy

suffering from secondary MR

having a contraindication to gadolinium-based contrast agent

having a pacemaker, defibrillator or any other contraindication to MRI

Trial design

Treatments tested in this trial

  • Standard echocardiography
  • 2D phase-contrast magnetic resonance imaging
  • 4D flow magnetic resonance imaging
  • Cardiac ultrafast ultrasound imaging

Treatment groups

160 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Ministry of Health, France

Collaborator

GIRCI IDF

Collaborator