MigraineNCT06953622
Establishment of a Clinical and Prognostic Follow-up Cohort of Migraine Patients With Patent Foramen Ovale
An observational study of Migraine and Patent Foramen Ovale, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migraine, Patent Foramen Ovale
- What is being tested?
- Conservative treatment, Antipaletet drug and Patent Foramen Ovale Closure
- Type of treatment
- Surgery or procedure
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All clinically confirmed migraine patients with PFO who met the inclusion criteria were included.
Who may be able to join
- 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.
Who cannot join
- Can not sign the informed consent form or cooperate with follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Yu Fu, 13671185050, lilac_fu@126.com
About this study
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.
- Conditions
- Migraine, Patent Foramen Ovale
- Being tested
- Conservative treatment, Antipaletet drug, Patent Foramen Ovale Closure
- Medical subject headings
- Migraine Disorders, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatmentDrug
Receive no antipaletet drug treatment and surgery
Antipaletet drugDrug
Use of antipaletet drugs.
Patent Foramen Ovale ClosureProcedure or surgery
Receive the surgery of Patent Foramen Ovale
| Study group | Role | What they receive |
|---|---|---|
| Conservative group | Don't use antiplatelet drugs or undergo patent foramen ovale closure. Receives: Drug: Conservative treatment | |
| Antiplatelet group | The application of antiplatelet drug. Receives: Drug: Antipaletet drug | |
| PFO group | Receive a patent foramen ovale closure surgery. Receives: Procedure: Patent Foramen Ovale Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of migraine attacks
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.
Measured: 3 months, 6 months, 1 year, 2 years and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953622
- Sponsor's protocol ID
- M2024296
- Status last verified
- Jul 2024
- First submitted
- 19 Aug 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Clinical and Prognostic Follow-up Cohort of Migraine Patients With Patent Foramen Ovale
- ClinicalTrials.gov ID
- NCT06953622
- Acronym / sponsor ID
- M2024296
- Conditions
- Migraine, Patent Foramen Ovale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative group | – | Drug: Conservative treatmentDon't use antiplatelet drugs or undergo patent foramen ovale closure. |
| Antiplatelet group | – | Drug: Antipaletet drugThe application of antiplatelet drug. |
| PFO group | – | Procedure: Patent Foramen Ovale ClosureReceive a patent foramen ovale closure surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All clinically confirmed migraine patients with PFO who met the inclusion criteria were included.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Can not sign the informed consent form or cooperate with follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative treatmentReceive no antipaletet drug treatment and surgery | Drug | Conservative group |
| Antipaletet drugUse of antipaletet drugs. | Drug | Antiplatelet group |
| Patent Foramen Ovale ClosureReceive the surgery of Patent Foramen Ovale | Procedure or surgery | PFO group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Patent Foramen Ovale, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Fu (13671185050, lilac_fu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of migraine attacks (time frame: 3 months, 6 months, 1 year, 2 years and 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.