Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion: Its Role in the Diagnosis of the Severity of Pulmonary Hypertension in Adults and in the Follow-up. Preliminary Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Nuclear magnetic resonance imaging
研究概览
简要总结
Pulmonary hypertension is a rare severe disease leading to cardiac insufficiency. Treatment depends on the severity of the disease.
This study evaluates cardiac MRI for the assessment of pulmonary hypertension severity and identification of parameters useful for the follow-up in order to adapt the medical treatment to status of the patient.
Evaluate if cardiac MRI can obviate right cardiac catheterization in the follow-up.
详细描述
Thirty patients will be enrolled and followed for 1 year after their inclusion.
Cardiac MRI will be performed at inclusion and at 3 months and 12 months. At the same periods, echocardiography and right heart catheterization will be performed too.
Morphological and functional parameters will be studied with MRI and correlated to invasive parameters and echocardiography too.
Morphological parameters are: volumes, cardiac cavities areas and ratios and position of the interventricular septum. Functional parameters are: ejection fractions of right and left cavities, flow in pulmonary artery, across mitral and tricuspid valves, temporal measurements in the pulmonary artery and auriculoventricular valves.
The invasive measurements are considered as the gold standard for this study. The classification of the severity is defined according to the parameters from right cardiac catheterization (4 grades with severity increasing between 1 and 4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients with pulmonary hypertension without specific treatment at inclusion
- •Etiologies include chronic embolic disease, systemic fibrosis, Gougerot Sjogren, drug induced hypertension, primary hypertension.
- •informed consent
- •affiliated to medical insurance.
排除标准
- •Left cardiac disease responsible for pulmonary hypertension, congenital cardiopathies
- •Pulmonary functional tests with important impairment (decrease in TPCmore than 30%, decrease In VEMS more than 30%
- •pregnancy
- •contraindications to MRI
- •without informed consent
- •without insurance
结局指标
主要结局
Nuclear magnetic resonance imaging
时间窗: Inclusion ; 3rd month ; 12th month
Correlation of cardiac results from the first MRI (Magnetic Resonance Imaging) to invasive measurements from the first or initial right heart catheterization and to echocardiography to know if cardiac MRI is able to predict severity of the disease
次要结局
未报告次要终点