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.
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
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
Parallel
Standard echocardiography
Diagnostic testRoutine ultrasound examination with standardized recordings for the study, incorporating volumetric assessment techniques
2D phase-contrast magnetic resonance imaging
Diagnostic testA cardiac MRI will be performed on a 1.5 Tesla system, including a biventricular function study with a series of short-axis slices, three long-axis slices, a 2D phase-contrast acquisition orthogonal to the aortic root. Additionally, standard T1 mapping sequences will be acquired on three short-axis slices, 15 minutes after the injection of 0.2 mmol/kg of body weight of gadolinium, for myocardial and blood T1 measurements.
4D flow magnetic resonance imaging
Diagnostic testA sagittal 4D flow acquisition lasting between 6 and 10 minutes of free breathing to cover all four cardiac chambers is added to the 2D acquisition.
Cardiac ultrafast ultrasound imaging
Diagnostic testUltrafast sequences are added to the standard echocardiography acquisition.
Absolute change in left ventricle end-diastolic volume
The primary outcome criterion will be the analysis of the association between the absolute change in LV end-diastolic volume (LVEDV) between baseline (M0) and 6 months after (M6) and mitral regurgitant volume at M0, as calculated by the different methods or MR severity estimated using the integrative TTE approach, adjusted for residual MR.
Mitral regurgitant volume
The primary outcome criterion will be the analysis of the association between the absolute change in LV end-diastolic volume (LVEDV) between baseline (M0) and 6 months after (M6) and mitral regurgitant volume at M0, as calculated by the different methods or MR severity estimated using the integrative TTE approach, adjusted for residual MR.
Absolute change in left ventricle end-diastolic volume
Same outcome as the primary outcome but in a subgroup of patients who have undergone percutaneous mitral regurgitation correction.
Mitral regurgitant volume
Same outcome as the primary outcome but in a subgroup of patients who have undergone percutaneous mitral regurgitation correction.
Absolute change in left ventricle end-diastolic volume
Same outcome as the primary outcome but in a subgroup of patients who have undergone surgical mitral regurgitation correction.
Mitral regurgitant volume
Same outcome as the primary outcome but in a subgroup of patients who have undergone surgical mitral regurgitation correction.
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
Ministry of Health, France
Collaborator
GIRCI IDF
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
