Patent Foramen Ovale Closure in Migraine

NCT06192173 | Completed

• 1 other identifier: YXLL-KY-2022(078)
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Patent Foramen Ovale

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Closure group

Migraine patients with PFO who managed with percutaneous PFO closure.

Procedure: Percutaneous PFO closure

Drug group

Migraine patients with PFO who treated with medicion.

Interventions

Percutaneous PFO closure PROCEDURE

Two kinds of interventional closure methods including DSA-guided and TEE-guided percutaneous intervention were performed on closure group.

Closure group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haiyan Wang: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, 250000, China

Location

MeSH Terms

Conditions

Migraine Disorders; Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Haiyan Wang

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: September 5, 2022
• Primary Completion: December 20, 2022
• Study Completion: May 20, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)