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临床试验/NCT00203333
NCT00203333已完成不适用

Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2002年4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
19
试验地点
1

研究概览

简要总结

People with epilepsy are at a higher risk for sudden unexpected death than the general population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this population, accounting for 10-50% of deaths for those with epilepsy. The risk for SUDEP is particularly high for those with refractory epilepsy. Several lines of evidence support a cardiac mechanism for SUDEP.

This study plans to determine:

  1. the frequency and types of cardiac arrhythmias that occur in this population and
  2. whether these are increased above the general population in the same age group.

Additionally, these data will be correlated to specific clinical data, including seizure history, anticonvulsant medications, and any accompanying clinical symptoms.

详细描述

By employing long-term electrocardiographic monitoring, this study plans to determine:

  1. the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled seizures and
  2. whether these are increased above the general population in the same age group.

The specific aims:

  1. Identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data.

  2. Correlate abnormal heart rates and rhythms to specific clinical data:

  3. seizure type,

  4. seizure frequency,

  5. probable location of seizure onset in the brain, when such data are available,

  6. duration of seizures, and

  7. type(s) and number of anticonvulsant medications being used.

  8. Correlate cardiac arrhythmias to clinical symptoms

研究设计

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

入排标准

年龄范围
16 Years 至 49 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Refractory epilepsy

排除标准

  • Other pre-existing heart conditions

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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