Genetic Polymorphisms in Idiopathic Mitral Valve Prolapse :A French Prospective Study Using a Genome Wide Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,179
- 试验地点
- 52
- 主要终点
- Genetic polymorphism identification
研究概览
简要总结
This prospective nation-wide (France) study aims to search for susceptibility genes in MVP using a genome wide analysis and comparing results obtained in 1000 patients with MVP and 1000 non-MVP subjects.
详细描述
Two MVP populations will be defined in that study, either with the classical Barlow (myxomatous) disease or the fibroelastic degenerescence (thin and redundant leaflets).
MVP adult patients (> 18 year-old) will be included if they present the following 1) or 2) criteria :
- 2D-echocardiographic mitral leaflet prolapse on the parasternal long-axis view > 2 mm AND leaflet thickness > 4 mm or mitral regurgitation > 2 + (using color Doppler)
- Previous surgery for pure severe mitral regurgitation due to MVP with Barlow disease or fibroelastic degenerescence (with operative report available)
Patients will be excluded in case of associated heart disease (hypertrophic cardiomyopathy, rheumatismal disease...) or syndromic disease (Marfan, Ehlers-Danlos...).
Around 30 (cardiology, cardiovascular surgery) french centers will participate to this study. An e-CRF will be used to collect clinical data. A genetic core lab will collect the DNA samples. An echocardiographic core lab will collect and read all the echo recordings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- 是
入选标准
- •for MVP patients :
- •Male or female subject ≥18 years
- •Affiliation to the French social insurance system
- •Written informed consent
- •Idiopathic MVP defined by the presence of criteria 1) and 2) OR of criterion 3) :
- •Echographic MVP > 2 mm on the left ventricular parasternal long-axis view
- •Echographic myxomatous valve (thickness > 4 mm) or significant mitral regurgitation (> 2 + using color Doppler)
- •History of mitral valve surgery for pure mitral regurgitation due to MVP (myxomatous or fibroelastic deficiency) with available detailed operative report.
排除标准
- •Presence of heart disease causing MVP (rheumatic, HCM...)
- •Syndromic disease (Marfan, Ehlers-Danlos...)
- •Inclusion criteria for healthy subject :
- •Male or female subject ≥40 years
- •Absence of MVP or absence of mitral valve dystrophy
- •Caucasian
结局指标
主要结局
Genetic polymorphism identification
时间窗: Day 1
次要结局
未报告次要终点