Status:

COMPLETED

Patent Foramen Ovale Closure in Migraine

Lead Sponsor:

Haiyan Wang

Conditions:

Migraine

Patent Foramen Ovale

Eligibility:

All Genders

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 effect...

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. H...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 5 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 20 2023

Estimated Enrollment :

138 Patients enrolled

Trial Details

Trial ID

NCT06192173

Start Date

September 5 2022

End Date

May 20 2023

Last Update

January 9 2024

Active Locations (1)

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1

The First Affiliated Hospital of Shandong First Medical University

Jinan, China, 250000