Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
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
研究组 & 干预措施
Contrast group
Migraine patients with PFO，who meet the criteria but don't agree to conduct closure of patent foramen ovale will be selected to this group.
Transcatheter closure group
Migraine patients with patent foreman ovale (PFO)，who meet the criteria and agree to conduct closure of patent foramen ovale will be selected to this group.
干预措施: transcatheter patent foreman ovale closure (Device)
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