Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval: COMPETE Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Responder rate
研究概览
简要总结
Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a multi-center cohort study aiming to find the correlation between PFO closure and migraine attacks.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 ；
- •Diagnosed migraine by ICHD-3
- •History of migraine longer than 1 year, and symptoms severely disturbing daily life.
- •TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt
- •Willing to participant and agree to follow-ups
- •Received at least three different types of migraine preventive drugs, the responder rate of previous therapy did not receive 50%.
排除标准
- •Migraine caused by other reason
- •Had TIA/stroke history
- •With contraindication or hypersensitive to anti-platelet or anticoagulation drugs.
- •With contraindication to PFO occlusion
结局指标
主要结局
Responder rate
时间窗: From baseline period to 12-month treatment period
Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase.
次要结局
- Migraine days change per month(From baseline period to 12-month treatment period)
- Number of migraine attacks change per month(From baseline period to 12-month treatment period)
- Percentage of complete migraine cessation(From baseline period to 12-month treatment period)
研究者
Pan Xiangbin
Principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital