MigraineNCT06192173
Patent Foramen Ovale Closure in Migraine
An observational study of Migraine and Patent Foramen Ovale, run by Haiyan Wang at 1 site in China.
Trial summary
The goal of this observational study is to retrospectively observe the effect of PFO closure and medication on migraine. The main questions it aims to answer are: Whether PFO closure is more effective in the treatment of migraine than traditional medical treatment What factors affect the effectiveness of migraine… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migraine, Patent Foramen Ovale
- What is being tested?
- Percutaneous PFO closure
- Type of treatment
- Surgery or procedure
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2022to 20 May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Migraine patients who diagnosed with PFO and HIT-6 ≥50
Who may be able to join
- Closure group:
- Migraine patients with grade II-III RLS of PFO confirmed by cTTE.
- HIT-6≥50.
- Meeting the surgical indications of PFO closure according to Chinese expert consensus on Prophylactic Closure of Patent foramen ovale published in March 2017
- Patients who have underwent PFO closure.
- Drug group:
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- Migraine patients with grade II-III RLS of PFO confirmed by cTTE.
- HIT-6 ≥ 50.
- Patients who have underwent drug treatment for 12 months.
Who cannot join
- Congenital heart diseases, cardiomyopathy, heart failure, valvular heart disease, arrhythmia, severe hypertension or other heart diseases.
- Patients with serious complications after closure.
- Patients who have other known triggers of migraine.
- Patients with incomplete follow-up data.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University
Jinan, 250000
About this study
Official title: Comparison of Short- and Medium- Term Efficacy of Patent Foramen Ovale Closure and Medication in the Treatment of Migraine
The goal of this observational study is to retrospectively observe the effect of PFO closure and medication on migraine. The main questions it aims to answer are:
- Whether PFO closure is more effective in the treatment of migraine than traditional medical treatment
- What factors affect the effectiveness of migraine treatment ?
Read more
Participants will undergo contrast transthoracic echocardiography to diagnose PFO and evaluate right-to-left shunt. They will be treated with medication and PFO closure respectively according to guidelines. HIT-6 and a questionnaire about migraine were obtained at the baseline and repeated at the 6-month and 12-month follow-up visits.
Researchers will compare closure group and drug group to see efficacy of two groups in treating migraine.
Read the detailed description
Migraine patients with PFO who were admitted to our hospital from January 2018 to August 2021 were enrolled.They will be treated with medication and PFO closure respectively according to guidelines. Headache impact test (HIT-6) and a questionnaire about migraine were obtained at the baseline and repeated at the 6th and 12th month follow-up visits.
- HIT-6 was used to assess migraine severity.
- Questionnaire included questions regarding average duration of migraine, migraine frequency, relief of migraine after treatment, family history and medication use.
- △HIT-6 is the difference between baseline and follow-up in HIT-6 and is used to assess migraine relief. The days of migraine attacks per month (MAD) were calculated by the product of the frequency of headache attacks and average duration of each attack. Therefore, the days of migraine remission per month (MRD)= MAD at the 6th or 12th month follow-up- MAD at baseline. In comparison with baseline, 50% decrease in the number of total attacks was considered responder.
- Four parameters were selected to evaluate the treatment effect: HIT-6, △HIT-6, MRD, and response rate.
- Conditions
- Migraine, Patent Foramen Ovale
- Being tested
- Percutaneous PFO 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.
Percutaneous PFO closureProcedure or surgery
Two kinds of interventional closure methods including DSA-guided and TEE-guided percutaneous intervention were performed on closure group.
| Study group | Role | What they receive |
|---|---|---|
| Closure group | Migraine patients with PFO who managed with percutaneous PFO closure. Receives: Procedure: Percutaneous PFO closure | |
| Drug group | Migraine patients with PFO who treated with medicion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache impact test (HIT-6)
HIT-6 is a self-report assessment tool that covers six dimensions (pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress) and widely used in headache impact surveys. Scores range from 36-78, < 49 indicating no effect, 50~55 some effect, 56~60 a relatively large effect, and > 60 severe effect. The higher HIT-6, the more severe the impact of headache on patients.
Measured: After recruiting, HIT-6 will be assessed and reported up to 12 weeks.
The days of migraine remission (MRD)
The days of migraine attacks per month (MAD) were calculated by the product of the frequency of headache attacks and average duration of each attack. Therefore, the days of migraine remission per month (MRD)= MAD at the 6th or 12th month follow-up- MAD at baseline
Measured: After recruiting, MRD will be assessed and reported up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start5 Sep 2022
- Primary completion20 Dec 2022
- Study completion20 May 2023
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.
- 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
- Retrospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haiyan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haiyan Wang, Qianfoshan Hospital
- Investigators
- Haiyan Wang, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192173
- Sponsor's protocol ID
- YXLL-KY-2022(078)
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short- and Medium- Term Efficacy of Patent Foramen Ovale Closure and Medication in the Treatment of Migraine
- ClinicalTrials.gov ID
- NCT06192173
- Acronym / sponsor ID
- YXLL-KY-2022(078)
- Conditions
- Migraine, Patent Foramen Ovale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Haiyan WangUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 5 Jan 2024 (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.
The goal of this observational study is to retrospectively observe the effect of PFO closure and medication on migraine. The main questions it aims to answer are:
- Whether PFO closure is more effective in the treatment of migraine than traditional medical treatment
- What factors affect the effectiveness of migraine treatment ?
Participants will undergo contrast transthoracic echocardiography to diagnose PFO and evaluate right-to-left shunt. They will be treated with medication and PFO closure respectively according to guidelines. HIT-6 and a questionnaire about migraine were obtained at the baseline and repeated at the 6-month and 12-month follow-up visits.
Researchers will compare closure group and drug group to see efficacy of two groups in treating migraine.
Detailed description
Migraine patients with PFO who were admitted to our hospital from January 2018 to August 2021 were enrolled.They will be treated with medication and PFO closure respectively according to guidelines. Headache impact test (HIT-6) and a questionnaire about migraine were obtained at the baseline and repeated at the 6th and 12th month follow-up visits.
- HIT-6 was used to assess migraine severity.
- Questionnaire included questions regarding average duration of migraine, migraine frequency, relief of migraine after treatment, family history and medication use.
- △HIT-6 is the difference between baseline and follow-up in HIT-6 and is used to assess migraine relief. The days of migraine attacks per month (MAD) were calculated by the product of the frequency of headache attacks and average duration of each attack. Therefore, the days of migraine remission per month (MRD)= MAD at the 6th or 12th month follow-up- MAD at baseline. In comparison with baseline, 50% decrease in the number of total attacks was considered responder.
- Four parameters were selected to evaluate the treatment effect: HIT-6, △HIT-6, MRD, and response rate.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closure group | – | Procedure: Percutaneous PFO closureMigraine patients with PFO who managed with percutaneous PFO closure. |
| Drug group | – | –Migraine patients with PFO who treated with medicion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Migraine patients who diagnosed with PFO and HIT-6 ≥50
Key inclusion criteria (9 listed)
- Migraine patients with grade II-III RLS of PFO confirmed by cTTE.
- HIT-6≥50.
- Meeting the surgical indications of PFO closure according to Chinese expert consensus on Prophylactic Closure of Patent foramen ovale published in March 2017
- Patients who have underwent PFO closure.
- Migraine patients with grade II-III RLS of PFO confirmed by cTTE.
Key exclusion criteria (4 listed)
- Congenital heart diseases, cardiomyopathy, heart failure, valvular heart disease, arrhythmia, severe hypertension or other heart diseases.
- Patients with serious complications after closure.
- Patients who have other known triggers of migraine.
- Patients with incomplete follow-up data.
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 |
|---|---|---|
| Percutaneous PFO closureTwo kinds of interventional closure methods including DSA-guided and TEE-guided percutaneous intervention were performed on closure group. | Procedure or surgery | Closure group |
Primary outcome
Headache impact test (HIT-6)
Time frame: After recruiting, HIT-6 will be assessed and reported up to 12 weeks.
HIT-6 is a self-report assessment tool that covers six dimensions (pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress) and widely used in headache impact surveys. Scores range from 36-78, < 49 indicating no effect, 50~55 some effect, 56~60 a relatively large effect, and > 60 severe effect. The higher HIT-6, the more severe the impact of headache on patients.
The days of migraine remission (MRD)
Time frame: After recruiting, MRD will be assessed and reported up to 12 weeks.
The days of migraine attacks per month (MAD) were calculated by the product of the frequency of headache attacks and average duration of each attack. Therefore, the days of migraine remission per month (MRD)= MAD at the 6th or 12th month follow-up- MAD at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Haiyan Wang principal investigator
Shandong First Medical University
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 Haiyan Wang 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 9 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: finished, as of the sponsor's last update on 9 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache impact test (HIT-6) (time frame: After recruiting, HIT-6 will be assessed and reported up to 12 weeks.). The study lists 2 primary outcomes in all. 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 9 Jan 2024.