Observational study on the link between PFO closure and migraine relief
Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval: COMPETE Cohort Study
This study is trying to see if closing a small hole in the heart can help people aged 18-65 who have frequent migraines feel better and have fewer headaches.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 242 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06033937 on ClinicalTrials.gov |
What this trial studies
This observational cohort study investigates the relationship between patent foramen ovale (PFO) closure and the frequency of migraine attacks in patients diagnosed with migraines. It aims to gather data from multiple centers to assess whether occluding PFO can lead to a reduction in migraine symptoms. Participants will be individuals aged 18-65 who have experienced migraines for over a year and have not found relief from at least three different preventive medications. The study will track the correlation between PFO closure and changes in migraine frequency and severity.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a history of migraines and diagnosed PFO.
Not a fit: Patients whose migraines are caused by factors other than PFO or who have contraindications to PFO occlusion may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into a potential treatment option for patients suffering from migraines associated with PFO.
How similar studies have performed: Previous randomized controlled trials have shown mixed results regarding the effectiveness of PFO occlusion for migraine treatment, making this study's approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing
- Fuwai Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Xiangbin Pan, MD
- Email: panxiangbin@fuwaihospital.org
- Phone: 88396666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.