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

NCT ID: NCT06953622

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Migraine Patent Foramen Ovale

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conservative group

Don't use antiplatelet drugs or undergo patent foramen ovale closure.

Conservative treatment

Intervention Type DRUG

Receive no antipaletet drug treatment and surgery

Antiplatelet group

The application of antiplatelet drug.

Antipaletet drug

Intervention Type DRUG

Use of antipaletet drugs.

PFO group

Receive a patent foramen ovale closure surgery.

Patent Foramen Ovale Closure

Intervention Type PROCEDURE

Receive the surgery of Patent Foramen Ovale

Interventions

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Conservative treatment

Receive no antipaletet drug treatment and surgery

Intervention Type DRUG

Antipaletet drug

Use of antipaletet drugs.

Intervention Type DRUG

Patent Foramen Ovale Closure

Receive the surgery of Patent Foramen Ovale

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu Fu

Role: CONTACT

13671185050

Facility Contacts

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Yu Fu

Role: primary

13671185050

Other Identifiers

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M2024296

Identifier Type: -

Identifier Source: org_study_id

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