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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Absolute change in left ventricle end-diastolic volume
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •suffering from renal disease with an eGFR CKD-EPI < 30 ml/min
- •pregnant or breastfeeding
- •under legal protection
- •Enrolled subjects:
- •with an incomplete or suboptimal ultrasound or MRI examination
- •who have not attended to the 6-month follow-up visit
- •with an intercurrent medical event
- •will be excluded.
研究组 & 干预措施
Mild mitral regurgitation
Patient suffuring from mild mitral regurgitation (n=30)
干预措施: Standard echocardiography (Diagnostic Test)
Mild mitral regurgitation
Patient suffuring from mild mitral regurgitation (n=30)
干预措施: 2D phase-contrast magnetic resonance imaging (Diagnostic Test)
Mild mitral regurgitation
Patient suffuring from mild mitral regurgitation (n=30)
干预措施: 4D flow magnetic resonance imaging (Diagnostic Test)
Mild mitral regurgitation
Patient suffuring from mild mitral regurgitation (n=30)
干预措施: Cardiac ultrafast ultrasound imaging (Diagnostic Test)
Moderate mitral regurgitation
Patient suffuring from moderate mitral regurgitation (n=30)
干预措施: Standard echocardiography (Diagnostic Test)
Moderate mitral regurgitation
Patient suffuring from moderate mitral regurgitation (n=30)
干预措施: 2D phase-contrast magnetic resonance imaging (Diagnostic Test)
Moderate mitral regurgitation
Patient suffuring from moderate mitral regurgitation (n=30)
干预措施: 4D flow magnetic resonance imaging (Diagnostic Test)
Moderate mitral regurgitation
Patient suffuring from moderate mitral regurgitation (n=30)
干预措施: Cardiac ultrafast ultrasound imaging (Diagnostic Test)
Severe mitral regurgitation
Patient suffuring from severe mitral regurgitation (n=100)
干预措施: Standard echocardiography (Diagnostic Test)
Severe mitral regurgitation
Patient suffuring from severe mitral regurgitation (n=100)
干预措施: 2D phase-contrast magnetic resonance imaging (Diagnostic Test)
Severe mitral regurgitation
Patient suffuring from severe mitral regurgitation (n=100)
干预措施: 4D flow magnetic resonance imaging (Diagnostic Test)
Severe mitral regurgitation
Patient suffuring from severe mitral regurgitation (n=100)
干预措施: Cardiac ultrafast ultrasound imaging (Diagnostic Test)
结局指标
主要结局
Absolute change in left ventricle end-diastolic volume
时间窗: 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.
Mitral regurgitant volume
时间窗: 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.
次要结局
- Mitral regurgitant volume(Baseline)
- Absolute change in left ventricle end-diastolic volume(Baseline, 6 months)
- Change from baseline in left ventricle remodeling(Baseline, 6 months)