Migraine, Patent Foramen Ovale
Conditions
Brief summary
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.
Interventions
DEVICEPFO device closure
Participants randomized into this group will take PFO device closure.
DRUGAspirin
Participants randomized into this group will take aspirin 200mg qd for 6 months.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 ； 2. Diagnosed migraine by ICHD-3 3. History of migraine longer than 1 year 4. TCD/TTE/TEE diagnosed patent foramen ovale 5. Willing to participant and agree to follow-ups 6. Undertook medication therapy for three months without a responder rate higher or equal to 50%
Exclusion criteria
1. Migraine caused by other reason 2. Had TIA/stroke history 3. Hypersensitive or hyposensitive to the study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate | 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. |
| Treatment safety | From baseline period to 12-month treatment period | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Migraine days change per month | From baseline period to 12-month treatment period | Change in the mean number of migraine days from baseline to treatment phase. |
| Number of migraine attacks change per month | From baseline period to 12-month treatment period | Change in the mean number of migraine attacks from baseline to treatment phase. |
| Percentage of migraine change | From baseline period to 12-month treatment period | Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase. |
Countries
China
Contacts
Primary ContactXiangbin Pan, MD
Backup ContactFengwen Zhang, MD
Outcome results
None listed