跳至主要内容
临床试验/NCT04944927
NCT04944927已完成不适用

Role of Alternating Hemiplegia of Childhood Genotype in Cardiac Repolarization. HEART: HEmiplegia Arrhythmia Retrospective Trial

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Measurement of QTc interval and all relevant cardiac repolarization measurements

研究概览

简要总结

Alternating Hemiplegia of Childhood (AHC) is a rare and severe disease that is in need of effective, and hopefully even curative, therapies. Afflicted patients suffer from severe paralyzing crises, often excruciatingly painful muscle spasms, severe often life threatening epileptic seizures, frequently severe developmental and psychiatric/psychological disabilities and other comorbidities, such as cardiac disturbances. Recent data indicate that AHC genotype is in relation to cardiac repolarization troubles and to cardiac arrhythmias. The primary hypothesis to explore is that there is an association between genotype and cardiac phenotype in AHC.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
12 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients that meet the clinical diagnostic criteria (Aicardi et al, 1995) for typical alternating hemiplegia with or without identified mutations in ATP1A
  • At least one ECG study is required.
  • Patients ages yearand more

排除标准

  • Informed consent or assent not obtainable
  • ATP1A3 testing not performed
  • No ECG studies are available

结局指标

主要结局

Measurement of QTc interval and all relevant cardiac repolarization measurements

时间窗: Day 1

Outcome measure: QTc interval and cardiac repolarization measurement in milliseconds.

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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