NCT02127294已完成不适用
Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
Yi Yang1 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2013年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Contrast-enhanced Transcranial Doppler
研究概览
简要总结
The purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders
- •Transcranial Doppler evidence of right-to-left shunt(RLS) and echocardiographic evidence of PFO，of which the degree is moderate to large RLS
- •Subjects who have not responded to or cannot take common migraine preventive medications
- •Willing to participate in follow-up visits
- •Additional Inclusion Criteria:
- •Transcatheter closure group: Closure of PFO is performed
- •Contrast group: Subjects who meet the Inclusion Criteria, but refuse to undergo closure procedure
排除标准
- •Seizure disorder
- •Other organic central nervous system disease
- •Subjects whose headaches are other than migraine, such as a result of traumatic head or neck injury
- •Evidence of alcohol, drug or substance abuse within the previous year
- •Additional Exclusion Criteria for Transcatheter closure group:
- •Subjects with intracardiac thrombus or tumor
- •Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina
- •Subjects with left ventricular aneurysm or akinesis
- •Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)
- •Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum
- •Subjects with contraindication to aspirin or Clopidogrel therapy
- •Pregnant or desire to become pregnant within the next year
结局指标
主要结局
Contrast-enhanced Transcranial Doppler
时间窗: within one year period
Patients in transcatheter closure group are required to perform contrast-enhanced Transcranial Doppler at 1 month, 3 month, 6 month and 1 year after closure, respectively.
次要结局
- Headache Impact Test-6(within one year period, at least 3 months)
研究者
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University
研究点 (1)
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