NCT06192173

Patent Foramen Ovale Closure in Migraine

Comparison of Short- and Medium- Term Efficacy of Patent Foramen Ovale Closure and Medication in the Treatment of Migraine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 138 (actual)
• Sponsor: Haiyan Wang · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Migraine
• Patent Foramen Ovale

Interventions

Type	Name	Description
PROCEDURE	Percutaneous PFO closure	Two kinds of interventional closure methods including DSA-guided and TEE-guided percutaneous intervention were performed on closure group.

Timeline

• Start date: 2022-09-05
• Primary completion: 2022-12-20
• Completion: 2023-05-20
• First posted: 2024-01-05
• Last updated: 2024-01-09

Locations

1 site across 1 country: China