Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter closure group | Experimental | Migraine patients with patent foreman ovale (PFO),who meet the criteria and agree to conduct closure of patent foramen ovale will be selected to this group. |
|
| Contrast group | No Intervention | Migraine patients with PFO,who meet the criteria but don't agree to conduct closure of patent foramen ovale will be selected to this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcatheter patent foreman ovale closure | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contrast-enhanced Transcranial Doppler | Patients in transcatheter closure group are required to perform contrast-enhanced Transcranial Doppler at 1 month, 3 month, 6 month and 1 year after closure, respectively. | within one year period |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Impact Test-6 | All patients complete HIT-6 score at baseline. Patients in transcatheter closure group follow-up at 1 month, 3 month, 6 month and 1 year after closure, respectively. Patients in contrast group follow-up twice during one year period. | within one year period, at least 3 months |
Not provided
Inclusion Criteria:
Additional Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion Criteria for Transcatheter closure group:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yi Yang, MD, PhD | The First Hospital of Jilin University | Study Chair |
| Yingqi Xing, MD, PhD | The First Hospital of Jilin University | Study Director |
| Yuzhu Guo | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22747847 | Background | Yang Y, Guo ZN, Wu J, Jin H, Wang X, Xu J, Feng J, Xing Y. Prevalence and extent of right-to-left shunt in migraine: a survey of 217 Chinese patients. Eur J Neurol. 2012 Oct;19(10):1367-72. doi: 10.1111/j.1468-1331.2012.03793.x. Epub 2012 Jun 30. | |
| 27966652 | Derived | Xing YQ, Guo YZ, Gao YS, Guo ZN, Niu PP, Yang Y. Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine (EASTFORM) Trial. Sci Rep. 2016 Dec 14;6:39081. doi: 10.1038/srep39081. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |