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COMPETE Cohort Study

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ClinicalTrials.gov Identifier: NCT06033937
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital

Study Description
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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.

Condition or disease Intervention/treatment
PFO - Patent Foramen Ovale Migraine Device: PFO occlusion

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 242 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval: COMPETE Cohort Study
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Groups and Cohorts
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Group/Cohort Intervention/treatment
Migraine Medication Group
PFO Occlusion Group Device: PFO occlusion
Patients in PFO occlusion group received PFO closure using devices.


Outcome Measures
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Primary Outcome Measures :
  1. Responder rate [ Time Frame: 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 :
  1. Migraine days change per month [ Time Frame: From baseline period to 12-month treatment period ]
    Change in the mean number of migraine days from baseline to treatment phase.

  2. Number of migraine attacks change per month [ Time Frame: From baseline period to 12-month treatment period ]
    Change in the mean number of migraine attacks from baseline to treatment phase.

  3. Percentage of complete migraine cessation [ Time Frame: From baseline period to 12-month treatment period ]
    Participants experienced complete migraine attacks cessation after treatment phase as compared to baseline phase.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06033937


Contacts
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Contact: Xiangbin Pan, MD 88396666 panxiangbin@fuwaihospital.org
Contact: Fengwen Zhang, MD 88396666 zhangfengwen08@126.com

Locations
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China, Beijing
Fuwai Hospital Recruiting
Beijing, Beijing, China, 100028
Contact: Xiangbin Pan, MD    88396666    panxiangbin@fuwaihospital.org   
Contact: Fengwen Zhang, MD    88396666    zhangfengwen08@126.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
More Information
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Responsible Party: Pan Xiangbin, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT06033937    
Other Study ID Numbers: 2022-1758-2
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023

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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
Additional relevant MeSH terms:
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Migraine Disorders
Foramen Ovale, Patent
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities