Migraine, PFO - 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 multi-center cohort study aiming to find the correlation between PFO closure and migraine attacks.
Interventions
DEVICEPFO occlusion
Patients in PFO occlusion group received PFO closure using devices.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
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, and symptoms severely disturbing daily life. 4. TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt 5. Willing to participant and agree to follow-ups 6. Received at least three different types of migraine preventive drugs, the responder rate of previous therapy did not receive 50%.
Exclusion criteria
1. Migraine caused by other reason 2. Had TIA/stroke history 3. With contraindication or hypersensitive to anti-platelet or anticoagulation drugs. 4. With contraindication to PFO occlusion
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. |
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 complete migraine cessation | From baseline period to 12-month treatment period | Participants experienced complete migraine attacks cessation after treatment phase as compared to baseline phase. |
Countries
China
Contacts
Primary ContactXiangbin Pan, MD
Backup ContactFengwen Zhang, MD
Outcome results
None listed