COMPETE Cohort Study

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval: COMPETE Cohort Study

Conditions
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PFO - Patent Foramen Ovale, Migraine

Intervention / Treatment
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* Device: PFO occlusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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%. Exclusion Criteria: Migraine caused by other reason Had TIA/stroke history With contraindication or hypersensitive to anti-platelet or anticoagulation drugs. With contraindication to PFO occlusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Migraine Medication Group<br> | |
| PFO Occlusion Group<br> | Device: PFO occlusion<br>* Patients in PFO occlusion group received PFO closure using devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |