Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 试验地点
- 2
- 主要终点
- Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia)
研究概览
简要总结
Mitral valve prolapse (MVP) is a frequent affection of the mitral valve or its sub-valvular apparatus with a prevalence of 2-3% in the general population. This valvular disease is generally considered as benign, but may at term evolve toward mitral valve regurgitation of various severity and/or arrhythmia.
Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography and only patients with significant mitral regurgitation will undergo subsequent examination (24-hour external loop recording, exercise ECG, cardiac MRI) and a close follow-up.
External loop recording and exercise ECG have an interest in the identification of patients presenting with arrhythmic complications, such as premature ventricular contractions, and in the global evaluation of hemodynamic consequences of the mitral regurgitation.
More recently, detection of myocardial fibrosis among patients with MVP and severe ventricular arrhythmia has been identified. Fibrosis could evolve independently of the valvular regurgitation's severity and could be a substrate (myocardial scar) leading to ventricular arrhythmia. However, no study has specifically characterized myocardial lesions among patients with MVP and none, or not significant, mitral regurgitation. Using cardiac magnetic resonance imaging (MRI), gold standard technique in myocardial imaging and characterization, and echocardiography, particularly speckle-tracking imaging, identification of static (fibrosis) and/or dynamic (ventricular systolic deformation patterns using speckle-tracking strain) myocardial lesions.
Identification of patients with impaired deformation patterns, fibrosis or with premature ventricular contractions may isolate a sub-group of patients with a higher risk of severe ventricular arrhythmia for whom a closer follow-up could be justified.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mitral valve prolapse diagnosed in echocardiography
- •Signed written consent
- •Affiliation to social security
- •No contraindication to MRI or exercise ECG
- •Age above 18
排除标准
- •Mitral valve prolapse with severe regurgitation and instable hemodynamic state requiring urgent surgery
- •Prior MRI with contrast within the last month
- •Prior diagnosis of primary cardiomyopathy potentially responsible for myocardial fibrosis
- •Contraindication to exercise ECG: severe handicap, poor physical capacity
- •Contraindication to MRI: implantable device, claustrophobia, metal debris
- •Renal insufficiency with creatinine clearance <30 ml/min or prior serious side effect related to infusion of a magnetic contrast agent
- •Pregnant or breast-feeding women
- •Minors <18 years old
- •Mental illness or incapacity with incapacity to obtain informed consent
结局指标
主要结局
Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia)
时间窗: Within 15 days
Occurrence of any ventricular arrythmia on external loop recording or exercise ECG
Evidence of myocardial fibrosis on cardiac MRI
时间窗: Within 15 days
Visualisation of any late gadolinium enhancement
次要结局
- Estimation of mitral regurgitation severity on echocardiography(At inclusion)
- Description and evaluation of ventricular myocardial deformation patterns(Within 15 days)
- Comparative evaluation of mitral regurgitation using echocardiography and cardiac MRI(Within 15 days)
研究者
Dr Olivier HUTTIN
Medical Doctor
Central Hospital, Nancy, France