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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 prospective, double-blind, multi-center, and randomized study designed to test the effectiveness of migraine alleviation by performing percutaneous closure of patent foramen ovale in patients who are also diagnosed with PFO and migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFO closure | Experimental |
| |
| Shame procedure | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PFO device closure | Device | Participants randomized into this group will take PFO device closure. |
|
| 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 |
| Treatment safety | Adverse events after medication treatment Adverse events after medication treatment Adverse events after medication treatment Adverse events after medication treatment Adverse events after medication treatment | 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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| 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 | China |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D054092 | Foramen Ovale, Patent |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Aspirin | Drug | Participants randomized into this group will take aspirin 200mg qd for 6 months. |
|
Change in the mean number of migraine attacks from baseline to treatment phase.
| From baseline period to 12-month treatment period |
| Percentage of migraine change | Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase. | From baseline period to 12-month treatment period |
| D009422 | Nervous System Diseases |
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |