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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Migraine Medication Group | |||
| PFO Occlusion Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PFO occlusion | Device | Patients in PFO occlusion group received PFO closure using devices. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate | 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. | From baseline period to 12-month treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Migraine days change per month | Change in the mean number of migraine days from baseline to treatment phase. | From baseline period to 12-month treatment period |
| Number of migraine attacks change per month |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with PFO and migraine who met the eligibility criteria are recruited for this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangbin Pan, MD | Contact | 88396666 | panxiangbin@fuwaihospital.org | |
| Fengwen Zhang, MD | Contact | 88396666 | zhangfengwen08@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Recruiting | Beijing | Beijing Municipality | 100028 | China |
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| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
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Change in the mean number of migraine attacks from baseline to treatment phase.
| From baseline period to 12-month treatment period |
| Percentage of complete migraine cessation | Participants experienced complete migraine attacks cessation after treatment phase as compared to baseline phase. | From baseline period to 12-month treatment period |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |