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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Patent Foramen Ovale
• Intervention / Treatment: Procedure: 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
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• China
  • Jinan, China, 250000
    • The First Affiliated Hospital of Shandong First Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Migraine patients who diagnosed with PFO and HIT-6 ≥50

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Closure group; Migraine patients with PFO who managed with percutaneous PFO closure.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	After recruiting, MRD will be assessed and reported up to 12 weeks.

Collaborators and Investigators

• Sponsor: Haiyan Wang
• Investigators: Principal Investigator: Haiyan Wang, The First Affiliated Hospital of Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): May 20, 2023

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 6, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Headache Disorders, Primary; Headache Disorders; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Migraine Disorders; Foramen Ovale, Patent
• Other Study ID Numbers: YXLL-KY-2022(078)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No