Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
138 participants
OBSERVATIONAL
2022-09-05
2023-05-20
Brief Summary
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* 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.
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Detailed Description
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1. HIT-6 was used to assess migraine severity.
2. Questionnaire included questions regarding average duration of migraine, migraine frequency, relief of migraine after treatment, family history and medication use.
3. △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.
4. Four parameters were selected to evaluate the treatment effect: HIT-6, △HIT-6, MRD, and response rate.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Closure group
Migraine patients with PFO who managed with percutaneous PFO closure.
Percutaneous PFO closure
Two kinds of interventional closure methods including DSA-guided and TEE-guided percutaneous intervention were performed on closure group.
Drug group
Migraine patients with PFO who treated with medicion.
No interventions assigned to this group
Interventions
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Percutaneous PFO closure
Two kinds of interventional closure methods including DSA-guided and TEE-guided percutaneous intervention were performed on closure group.
Eligibility Criteria
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Inclusion Criteria
* 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:
* Migraine patients with grade II-III RLS of PFO confirmed by cTTE.
* HIT-6 ≥ 50.
* Patients who have underwent drug treatment for 12 months.
Exclusion Criteria
* Patients with serious complications after closure.
* Patients who have other known triggers of migraine.
* Patients with incomplete follow-up data.
ALL
No
Sponsors
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Haiyan Wang
OTHER
Responsible Party
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Haiyan Wang
Director
Principal Investigators
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Haiyan Wang
Role: PRINCIPAL_INVESTIGATOR
Shandong First Medical University
Locations
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The First Affiliated Hospital of Shandong First Medical University
Jinan, , China
Countries
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Other Identifiers
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YXLL-KY-2022(078)
Identifier Type: -
Identifier Source: org_study_id
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