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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closure group | Migraine patients with PFO who managed with percutaneous PFO closure. |
| |
| Drug group | Migraine patients with PFO who treated with medicion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous PFO closure | Procedure | Two kinds of interventional closure methods including DSA-guided and TEE-guided percutaneous intervention were performed on closure group. |
|
| 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. |
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Inclusion Criteria:
Closure group:
Drug group:
Exclusion Criteria:
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Migraine patients who diagnosed with PFO and HIT-6 ≥50
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| Name | Affiliation | Role |
|---|---|---|
| Haiyan Wang | Shandong First Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University | Jinan | 250000 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 2, 2024 | |
| Reset | Sep 17, 2024 | |
| Release | Jan 13, 2025 | |
| Reset | Feb 5, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 2, 2024 | Sep 17, 2024 | |||
| Jan 13, 2025 |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D054092 | Foramen Ovale, Patent |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Feb 5, 2025 |
| D009422 | Nervous System Diseases |
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |