COMPETE Cohort Study

Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval: COMPETE Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine; PFO - Patent Foramen Ovale
• Intervention / Treatment: Device: PFO occlusion

• Study Type: Observational
• Enrollment (Estimated): 242

Contacts and Locations

• Study Contact: Name: Xiangbin Pan, MD; Phone Number: 88396666; Email: panxiangbin@fuwaihospital.org
• Study Contact Backup: Name: Fengwen Zhang, MD; Phone Number: 88396666; Email: zhangfengwen08@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100028
      • Recruiting
      • Fuwai Hospital
      • Contact: Xiangbin Pan, MD; Phone Number: 88396666; Email: panxiangbin@fuwaihospital.org
      • Contact: Fengwen Zhang, MD; Phone Number: 88396666; Email: zhangfengwen08@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with PFO and migraine who met the eligibility criteria are recruited for this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Migraine Medication Group
PFO Occlusion Group	Device: PFO occlusion; Patients in PFO occlusion group received PFO closure using devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rate	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.	From baseline period to 12-month treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine days change per month	Change in the mean number of migraine days from baseline to treatment phase.	From baseline period to 12-month treatment period
Number of migraine attacks change per month	Change in the mean number of migraine attacks from baseline to treatment phase.	From baseline period to 12-month treatment period
Percentage of complete migraine cessation	Participants experienced complete migraine attacks cessation after treatment phase as compared to baseline phase.	From baseline period to 12-month treatment period

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Headache Disorders, Primary; Headache Disorders; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Migraine Disorders; Foramen Ovale, Patent
• Other Study ID Numbers: 2022-1758-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No