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NCT Number: NCT06953622

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

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.

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Key information

Conditions

Migraine Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Headache Disorders Headache Disorders, Primary Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Migraine Disorders Nervous System Diseases Patent Foramen Ovale

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conservative treatment

Drug

Receive no antipaletet drug treatment and surgery

Antipaletet drug

Drug

Use of antipaletet drugs.

Patent Foramen Ovale Closure

Procedure

Receive the surgery of Patent Foramen Ovale

Primary outcomes

  1. The changes of migraine attacks

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Fu

CONTACT

[email protected]

13671185050

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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