PFO - Patent Foramen OvaleNCT06033937
COMPETE Cohort Study
An observational study of PFO - Patent Foramen Ovale and Migraine, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PFO - Patent Foramen Ovale, Migraine
- What is being tested?
- PFO occlusion
- Type of treatment
- Medical device
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with PFO and migraine who met the eligibility criteria are recruited for this study.
Who may be able to join
- Age 18-65 ；
- Diagnosed migraine by ICHD-3
- History of migraine longer than 1 year, and symptoms severely disturbing daily life.
- TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt
- Willing to participant and agree to follow-ups
- Received at least three different types of migraine preventive drugs, the responder rate of previous therapy did not receive 50%.
Who cannot join
- Migraine caused by other reason
- Had TIA/stroke history
- With contraindication or hypersensitive to anti-platelet or anticoagulation drugs.
- With contraindication to PFO occlusion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100028
Xiangbin Pan, MD, 88396666, panxiangbin@fuwaihospital.org
Fengwen Zhang, MD, 88396666, zhangfengwen08@126.com
About this study
Official title: Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval: COMPETE Cohort Study
Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a multi-center cohort study aiming to find the correlation between PFO closure and migraine attacks.
- Conditions
- PFO - Patent Foramen Ovale, Migraine
- Being tested
- PFO occlusion
- Medical subject headings
- Foramen Ovale, Patent, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFO occlusionDevice
Patients in PFO occlusion group received PFO closure using devices.
| Study group | Role | What they receive |
|---|---|---|
| Migraine Medication Group | Not described | |
| PFO Occlusion Group | Not described Receives: Device: PFO occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate
Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase.
Measured: From baseline period to 12-month treatment period
Secondary outcomes (3)
Migraine days change per month
Change in the mean number of migraine days from baseline to treatment phase.
Measured: From baseline period to 12-month treatment period
Number of migraine attacks change per month
Change in the mean number of migraine attacks from baseline to treatment phase.
Measured: From baseline period to 12-month treatment period
Percentage of complete migraine cessation
Participants experienced complete migraine attacks cessation after treatment phase as compared to baseline phase.
Measured: From baseline period to 12-month treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PFO - Patent Foramen OvaleStudies of the same condition, open and under way.
- 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
- 242 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033937
- Sponsor's protocol ID
- 2022-1758-2
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval: COMPETE Cohort Study
- ClinicalTrials.gov ID
- NCT06033937
- Acronym / sponsor ID
- 2022-1758-2
- Conditions
- PFO - Patent Foramen Ovale, Migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 13 Sep 2023 (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.
Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a multi-center cohort study aiming to find the correlation between PFO closure and migraine attacks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraine Medication Group | – | – |
| PFO Occlusion Group | – | Device: PFO occlusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with PFO and migraine who met the eligibility criteria are recruited for this study.
Key inclusion criteria (6 listed)
- Age 18-65 ；
- Diagnosed migraine by ICHD-3
- History of migraine longer than 1 year, and symptoms severely disturbing daily life.
- TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt
- Willing to participant and agree to follow-ups
Key exclusion criteria (4 listed)
- Migraine caused by other reason
- Had TIA/stroke history
- With contraindication or hypersensitive to anti-platelet or anticoagulation drugs.
- With contraindication to PFO occlusion
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 |
|---|---|---|
| PFO occlusionPatients in PFO occlusion group received PFO closure using devices. | Device | PFO Occlusion Group |
Primary outcome
Responder rate
Time frame: From baseline period to 12-month treatment period
Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase.
3 secondary outcomes
Migraine days change per month
Time frame: From baseline period to 12-month treatment period
Number of migraine attacks change per month
Time frame: From baseline period to 12-month treatment period
Percentage of complete migraine cessation
Time frame: From baseline period to 12-month treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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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. This study is not recruiting at the moment.
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 PFO - Patent Foramen Ovale and Migraine, run by Chinese Academy of Medical Sciences, Fuwai 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangbin Pan, MD (88396666, panxiangbin@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder rate (time frame: From baseline period to 12-month treatment period). 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 13 Sep 2023.