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临床试验/NCT02560844
NCT02560844已完成不适用

Cardiomyopathy Arrhythmia Risk Evaluation

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2015年7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
164
试验地点
1
主要终点
Proportion of patients with appropriate implantable cardioverter defibrillator (ICD) shocks

研究概览

简要总结

This study will evaluate the prognostic utility of novel ECG markers of electrical instability in patients with cardiomyopathy.

详细描述

Baseline ECG markers of electrical instability will be measured in patients with cardiomyopathy. These ECG markers will be evaluated from a clinical Holter recording. All patients will have a primary implantable cardioverter defibrillator (ICD) as part of their clinical care. Patients will be followed prospectively for 2 years to evaluate the primary outcome of appropriate ICD shocks. Multivariable modelling will be performed to determine whether the ECG markers of electrical instability independently predict the primary clinical outcome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • cardiomyopathy, primary prevention ICD

排除标准

  • brady-pacing requirement

结局指标

主要结局

Proportion of patients with appropriate implantable cardioverter defibrillator (ICD) shocks

时间窗: 2 years

Proportion is from 0 (no patients with shocks) to 100% (all patients receive shocks)

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 (1)

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