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NCT06192173 | COMPLETED | Migraine

Patent Foramen Ovale Closure in Migraine
Sponsor:

H annoying Wang

Information provided by (Responsible Party):

H annoying Wang

Brief 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 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.

Condition or disease

Migraine

Patent Foramen Ovale

Intervention/treatment

Percutaneous PFO closure

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. 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 138 participants
Official Title : Comparison of Short- and Medium- Term Efficacy of Patent Foramen Ovale Closure and Medication in the Treatment of Migraine
Actual Study Start Date : 2022-09-05
Estimated Primary Completion Date : 2022-12-20
Estimated Study Completion Date : 2023-05-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 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
      • * 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
      • * 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.
Patent Foramen Ovale Closure in Migraine

Location Details

NCT06192173

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Locations

Not yet recruiting

China,

The First Affiliated Hospital of Shandong First Medical University

Women, China, 250000