COMPETE Cohort Study

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06033937

Collaborator

(none)

242

Enrollment

Location

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
PFO - Patent Foramen Ovale Migraine	Device: PFO occlusion

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

242 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Migraine Medication Group

PFO Occlusion Group

Device: PFO occlusion

Patients in PFO occlusion group received PFO closure using devices.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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%.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuwai Hospital	Beijing	Beijing	China	100028

Sponsors and Collaborators

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Migraine Disorders

Foramen Ovale, Patent

Study Results

No Results Posted as of Sep 13, 2023