COMPETE Cohort Study

NCT06033937 | Unknown FDA Device

• 1 other identifier: 2022-1758-2
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

PFO - Patent Foramen Ovale; Migraine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Migraine days change per month

  From baseline period to 12-month treatment period

• Number of migraine attacks change per month

  From baseline period to 12-month treatment period

• Percentage of complete migraine cessation

  From baseline period to 12-month treatment period

Study Arms (2)

Migraine Medication Group

PFO Occlusion Group

Device: PFO occlusion

Interventions

PFO occlusion DEVICE

Patients in PFO occlusion group received PFO closure using devices.

PFO Occlusion Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age 18-65 ；
• Diagnosed migraine by ICHD-3
• History of migraine longer than 1 year, and symptoms severely disturbing daily life.
• TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt
• Willing to participant and agree to follow-ups
• Received at least three different types of migraine preventive drugs, the responder rate of previous therapy did not receive 50%.

You may not qualify if:

• Migraine caused by other reason
• Had TIA/stroke history
• With contraindication or hypersensitive to anti-platelet or anticoagulation drugs.
• With contraindication to PFO occlusion

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100028, China

RECRUITING

MeSH Terms

Conditions

Foramen Ovale, Patent; Migraine Disorders

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Xiangbin Pan, MD

CONTACT

88396666; panxiangbin@fuwaihospital.org

Fengwen Zhang, MD

CONTACT

88396666; zhangfengwen08@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CN (1)