COMPETE Cohort Study

Recruiting

• Conditions: PFO - Patent Foramen Ovale; Migraine
• Interventions: Device: PFO occlusion

• Registration Number: NCT06033937
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-05
• Last Update Submitted: 2023-09-05
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-01-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PFO Occlusion Group	PFO occlusion	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China