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临床试验/NCT02852018
NCT02852018已完成不适用

Identification of Genetic Markers Modulating Rhythmic Risk Among Patients With Severe Cardiomyopathy

Nantes University Hospital18 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,500
试验地点
18
主要终点
Prevalence of polymorphisms pre-selected candidates (or by direct sequencing by High Resolution Melting).

研究概览

简要总结

The aim of this project is to identify common genetic polymorphisms associated with the occurrence of rhythmic events in patients with severe cardiomyopathy.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients implanted for primary prevention, an implantable cardioverter defibrillator (ICD) single or double room, for severe cardiomyopathy (EF <35%)
  • Patients with ischemic cardiomyopathy or idiopathic dilated cardiomyopathy.- "Appropriate treatment" group: patients who had a rhythmic event (before or after inclusion) appropriately treated either by administering an electric shock or by antiarrhythmic stimulation
  • Group "no event" patients who have never received treatment or electrical antiarrhythmic stimulation and with a minimum follow-up of three years before inclusion and did not receive proper treatment during the follow up period of the study

排除标准

  • Patients implanted with an ICD for primary prevention in the context of a family hereditary disease (long QT syndrome, Brugada syndrome, hypertrophic cardiomyopathy, ventricular tachycardia catecholergic right ventricular dysplasia ...).
  • Patients with left ventricular function greater than 35%.
  • Patients implanted with a defibrillator function resynchronization.
  • Patients minors, adults under guardianship and protected persons are eligible under this project.

结局指标

主要结局

Prevalence of polymorphisms pre-selected candidates (or by direct sequencing by High Resolution Melting).

时间窗: 4 years

Identification of polymorphisms frequent (> 5% in the general population) by association study ( "Genome Wide Association Study '(GWAS)) using genotyping technology broadband Axiom (Affymetrix).

时间窗: 4 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (18)

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