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ID06953622

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

Led by Peking University Third Hospital · Updated on 2025-05-01

330

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are establishing a headache center in China to study migraine patients who also have patent foramen ovale (PFO). The study aims to explore different treatment options for this combination, identify factors that may influence outcomes, and develop models to predict prognosis. The goal is to improve understanding and care for patients with both conditions. Participants will be assigned to one of three groups based on treatment approach: a conservative group that does not use antiplatelet drugs or undergo PFO closure surgery, a group that receives antiplatelet drug treatment, and a group that undergoes PFO closure surgery. The study is observational and will follow patients over time to monitor their condition. During the study, participants will be regularly monitored for changes in migraine attacks at 3 months, 6 months, 1 year, 2 years, and 3 years. The study involves clinical, imaging, and laboratory examinations to gather detailed information. Participants will be followed up to assess the effects of their treatment approach and factors influencing migraine outcomes with PFO.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Unable to sign the informed consent form or cooperate with follow-up

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Long-term Monitoring

Duration - Up to 3 years

Participants are followed over time to monitor changes in migraine attacks and health status depending on their assigned group: conservative treatment, antiplatelet drug use, or patent foramen ovale closure surgery.

Visits at 3 months, 6 months, 1 year, 2 years, and 3 years

Trial Site Locations

Total: 1 location

1

Peking University Third Hospital

Beijing, China

Actively Recruiting

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Research Team

Y

Yu Fu

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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