COMPETE Cohort Study

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Enrolling

Conditions: PFO - Patent Foramen Ovale; Migraine

Treatments: Device: PFO occlusion

Study type: Observational

Funder types: Other

Identifiers

NCT06033937

2022-1758-2

Details and patient eligibility

About

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.

Enrollment: 242 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

242 participants in 2 patient groups

Migraine Medication Group

PFO Occlusion Group

Treatment:

Device: PFO occlusion