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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06953622
Enrollment
330
Registered
2025-05-01
Start date
2024-01-01
Completion date
2026-12-31
Last updated
2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine, Patent Foramen Ovale

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.

Interventions

DRUGConservative treatment

Receive no antipaletet drug treatment and surgery

DRUGAntipaletet drug

Use of antipaletet drugs.

Receive the surgery of Patent Foramen Ovale

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The changes of migraine attacks3 months, 6 months, 1 year, 2 years and 3 yearsMigraine 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.

Countries

China

Contacts

Primary ContactYu Fu
lilac_fu@126.com13671185050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026