Establishment of a Clinical and Prognostic Follow-up Cohort of Migraine Patients With Patent Foramen Ovale

Recruiting

• Conditions: Migraine; Patent Foramen Ovale
• Interventions: Drug: Conservative treatment; Drug: Antipaletet drug; Procedure: Patent Foramen Ovale Closure

• Registration Number: NCT06953622
• Lead Sponsor: Peking University Third Hospital

Brief Summary

To establish a headache center in China that combines clinical, imaging and laboratory examinations, explore the feasible treatment options for migraine combined with patent foramen ovale, and search for the possible influencing factors, construct models that influence prognosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-07
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Meet the diagnostic criteria for migraine in the International Classification of Headache (ICHD-3);
• Confirmation of patent foramen ovale through transthoracic echocardiography(TTE) or transesophageal echocardiography(TEE)/right heart contrast echocardiography
• Agree to participate in the study and sign the informed consent form.

Exclusion Criteria

• Can not sign the informed consent form or cooperate with follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conservative group	Conservative treatment	Don't use antiplatelet drugs or undergo patent foramen ovale closure.
Antiplatelet group	Antipaletet drug	The application of antiplatelet drug.
PFO group	Patent Foramen Ovale Closure	Receive a patent foramen ovale closure surgery.

Primary Outcome Measures

Name	Time	Method
The changes of migraine attacks	3 months, 6 months, 1 year, 2 years and 3 years	Migraine attacks are an important indicator of improvement in symptoms. The comparison measures included headache frequency, duration, pain degree, VAS scores, HIT-6 scores, HAMA, HAMD, and PSQI.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China