Comparison of Short- and Medium- Term Efficacy of Patent Foramen Ovale Closure and Medication in the Treatment of Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Headache impact test (HIT-6)
研究概览
简要总结
The goal of this observational study is to retrospectively observe the effect of PFO closure and medication on migraine. The main questions it aims to answer are:
- Whether PFO closure is more effective in the treatment of migraine than traditional medical treatment
- What factors affect the effectiveness of migraine treatment ?
Participants will undergo contrast transthoracic echocardiography to diagnose PFO and evaluate right-to-left shunt. They will be treated with medication and PFO closure respectively according to guidelines. HIT-6 and a questionnaire about migraine were obtained at the baseline and repeated at the 6-month and 12-month follow-up visits.
Researchers will compare closure group and drug group to see efficacy of two groups in treating migraine.
详细描述
Migraine patients with PFO who were admitted to our hospital from January 2018 to August 2021 were enrolled.They will be treated with medication and PFO closure respectively according to guidelines. Headache impact test (HIT-6) and a questionnaire about migraine were obtained at the baseline and repeated at the 6th and 12th month follow-up visits.
- HIT-6 was used to assess migraine severity.
- Questionnaire included questions regarding average duration of migraine, migraine frequency, relief of migraine after treatment, family history and medication use.
- △HIT-6 is the difference between baseline and follow-up in HIT-6 and is used to assess migraine relief. The days of migraine attacks per month (MAD) were calculated by the product of the frequency of headache attacks and average duration of each attack. Therefore, the days of migraine remission per month (MRD)= MAD at the 6th or 12th month follow-up- MAD at baseline. In comparison with baseline, 50% decrease in the number of total attacks was considered responder.
- Four parameters were selected to evaluate the treatment effect: HIT-6, △HIT-6, MRD, and response rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Closure group:
- •Migraine patients with grade II-III RLS of PFO confirmed by cTTE.
- •Meeting the surgical indications of PFO closure according to Chinese expert consensus on Prophylactic Closure of Patent foramen ovale published in March 2017
- •Patients who have underwent PFO closure.
- •Drug group:
- •Migraine patients with grade II-III RLS of PFO confirmed by cTTE.
- •Patients who have underwent drug treatment for 12 months.
排除标准
- •Congenital heart diseases, cardiomyopathy, heart failure, valvular heart disease, arrhythmia, severe hypertension or other heart diseases.
- •Patients with serious complications after closure.
- •Patients who have other known triggers of migraine.
- •Patients with incomplete follow-up data.
结局指标
主要结局
Headache impact test (HIT-6)
时间窗: After recruiting, HIT-6 will be assessed and reported up to 12 weeks.
HIT-6 is a self-report assessment tool that covers six dimensions (pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress) and widely used in headache impact surveys. Scores range from 36-78, \< 49 indicating no effect, 50\~55 some effect, 56\~60 a relatively large effect, and \> 60 severe effect. The higher HIT-6, the more severe the impact of headache on patients.
The days of migraine remission (MRD)
时间窗: After recruiting, MRD will be assessed and reported up to 12 weeks.
The days of migraine attacks per month (MAD) were calculated by the product of the frequency of headache attacks and average duration of each attack. Therefore, the days of migraine remission per month (MRD)= MAD at the 6th or 12th month follow-up- MAD at baseline
次要结局
未报告次要终点
研究者
Haiyan Wang
Director
Qianfoshan Hospital