Imaging by 4 DFlow in Patients With Tetralogy of Fallot
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparison of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI.
研究概览
简要总结
Conventionnal cadiac magnetic resonance (CMR) is the reference to assess changes in right heart flow and pulmonary artery hemodynamics in patients with repaired Tetralogy of Fallot.
4D Flow CMR Imaging is a new imaging modality able to assess all of these parameters faster (8 min vs 30 min) and more comfortably.
The aim of this study is to compare conventionnal CMR and 4D Flow CMR for the assessment of these parameters (ventricular volume, ventricular systolic function, and regurgitation of the pulmonary pathway).
详细描述
Congenital heart disease, or corrected heart disease requires regular, specialized follow-up throughout the life of these patients. Among the recommended examinations, cardiac MRI is the reference for functionnal ventricles assessment (volume/systolic function), particularly for the right ventricle.
Among these pathologies, the tetralogy of Fallot is indicative of the increasing importance of cardiac MRI. In this disease, strong parameters has been identifies for the follow to prevent right ventricle dysfunction and ventricular arrhythmias. They rely on right ventricle volumes and on the pulmonary artery regurgitation, both using cardiac MRI.
However, this imaging modality imposes constraints such as a long acquisition times (30 to 40 min) or the need to hold apneas, which may render the procedure uncomfortable, even more in the case of very young patients.
The idea of exploring a new imaging modality is therefore based on the willingness to offer a faster and more comfortable examination. 4D Flow MRI could enable conventionnal parameters, detection of both normal and abnormal right heart flow patterns, and may allow comprehensive analysis of post-surgically altered geometries and hemodynamics.
4D Flow MRI cardiac imaging is :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- children from the age of 10 and above without any upper age limit;
- •giving their informed consent for the study;
- •with a corrected tetralogy of Fallot;
- •sent for a follow-up imaging examination with endomyocardial fibrosis screening;
排除标准
- •- pregnant woman;
- •children <10 years old;
- •All contraindications inherent to MRI: (claustrophobia, ferromagnetic intracorporeal foreign bodies)
- •Contraindication to contrast media injection (Gadolinium)
研究组 & 干预措施
4D magnetic resonance imaging
MRI, 4D imaging, acquisition and analysis of 4D cardiac MRI images-A single, faster acquisition (8 to 15 minutes).
干预措施: magnetic resonance imaging (Procedure)
2D magnetic resonance imaging
MRI, 2D imaging, acquisition and analysis of 2D cardiac MRI
干预措施: magnetic resonance imaging (Procedure)
结局指标
主要结局
Comparison of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI.
时间窗: 20 min
Assessment of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI : regurgitation volume (ml) and regurgitation fraction (%).
次要结局
- Compare the evaluation of right ventricle volumes using 2D MRI and 4D Flow MRI.(20 min)