Patent Foramen Ovale Closure in 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.

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Key information

Conditions

Migraine Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Headache Disorders Headache Disorders, Primary Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Migraine Disorders Nervous System Diseases Patent Foramen Ovale

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Shandong First Medical University

Jinan, 250000, China

About this study

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.

HIT-6 was used to assess migraine severity.
Questionnaire included questions regarding average duration of migraine, migraine frequency, relief of migraine after treatment, family history and medication use.
△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.
Four parameters were selected to evaluate the treatment effect: HIT-6, △HIT-6, MRD, and response rate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous PFO closure

Procedure

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

Primary outcomes

Headache impact test (HIT-6)

Time frame: After recruiting, HIT-6 will be assessed and reported up to 12 weeks.

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.
The days of migraine remission (MRD)

Time frame: After recruiting, MRD will be assessed and reported up to 12 weeks.

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

Sponsors and collaborators

Lead sponsor

Haiyan Wang

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Jan 5, 2024
Registry last updated: Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed