Standard echocardiography
Diagnostic TestRoutine ultrasound examination with standardized recordings for the study, incorporating volumetric assessment techniques
Other names: Cardiac echography, TTE, Heart ultrasounds
NCT Number: NCT07066904
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.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Not applicable
Groupe hospitalier Paris Saint-Joseph - hôpital Marie-Lannelongue, Le Plessis-Robinson, France
Mitral Regurgitation (MR) is a widely prevalent valvular disease. The decision to refer patients for intervention relies on the precise quantification of MR using the mitral regurgitant volume. This quantification is primarily performed through transthoracic echocardiography (TTE), but its accuracy is limited by operator dependency and acoustic windows.
Magnetic resonance imaging (MRI) is now considered the preferred alternative technique for measuring mitral regurgitant volume using 2D phase-contrast sequences. However, it requires significant expertise from specialized centers.
4D flow MRI enables the recording of blood flow velocities in all directions across the entire cardiac volume and has demonstrated superiority over 2D MRI in other valvular diseases. However, limited data are available for validating the estimation of mitral regurgitation using 4DFlow-MRI, mainly due to the absence of a reference technique. As previously proposed for comparisons between 2D MRI and TTE, ventricular remodeling progression will be used as the evaluation criterion.
Primary Objective:
The main goal is to demonstrate that mitral regurgitant volume assessed by 4DFlow-MRI is more strongly correlated with left ventricular (LV) remodeling progression after correction or persistence of MR than mitral regurgitant volume assessed by 2D MRI or TTE, after adjustment for residual MR.
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.
Secondary Objectives:
Secondary Outcomes Criteria:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects
Exclusion criteria
Subjects
Enrolled subjects:
will be excluded.
Routine ultrasound examination with standardized recordings for the study, incorporating volumetric assessment techniques
Other names: Cardiac echography, TTE, Heart ultrasounds
A 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.
Other names: 2D MRI, Cardiac magnetic resonance imaging, CMR
A 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.
Other names: 4D MRI
Ultrafast sequences are added to the standard echocardiography acquisition.
Other names: ultrafast echocardiography
Time frame: Baseline, 6 months
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.
Time frame: Baseline
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.
Time frame: Baseline, 6 months
Same outcome as the primary outcome but in a subgroup of patients who have undergone percutaneous mitral regurgitation correction.
Time frame: Baseline
Same outcome as the primary outcome but in a subgroup of patients who have undergone percutaneous mitral regurgitation correction.
Time frame: Baseline, 6 months
Same outcome as the primary outcome but in a subgroup of patients who have undergone surgical mitral regurgitation correction.
Time frame: Baseline
Same outcome as the primary outcome but in a subgroup of patients who have undergone surgical mitral regurgitation correction.
Time frame: Baseline, 6 months
Same outcome as the primary outcome but mesured using ultrafast ultrasound imaging compared to the 3 other imaging techniques performed in the study.
Time frame: Baseline
Same outcome as the primary outcome but mesured using ultrafast ultrasound imaging compared to the 3 other imaging techniques performed in the study.
Time frame: Baseline, 6 months
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: FLAME
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