Migraine Clinical Trial
— EASTFORMOfficial title:
Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
Verified date | January 2016 |
Source | First Hospital of Jilin University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
The purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine.
Status | Completed |
Enrollment | 258 |
Est. completion date | January 2016 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders - Transcranial Doppler evidence of right-to-left shunt(RLS) and echocardiographic evidence of PFO,of which the degree is moderate to large RLS - Subjects who have not responded to or cannot take common migraine preventive medications - Willing to participate in follow-up visits Additional Inclusion Criteria: - Transcatheter closure group: Closure of PFO is performed - Contrast group: Subjects who meet the Inclusion Criteria, but refuse to undergo closure procedure Exclusion Criteria: - Seizure disorder - Other organic central nervous system disease - Subjects whose headaches are other than migraine, such as a result of traumatic head or neck injury - Evidence of alcohol, drug or substance abuse within the previous year Additional Exclusion Criteria for Transcatheter closure group: - Subjects with intracardiac thrombus or tumor - Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina - Subjects with left ventricular aneurysm or akinesis - Subjects with atrial fibrillation/atrial flutter (chronic or intermittent) - Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum - Subjects with contraindication to aspirin or Clopidogrel therapy - Pregnant or desire to become pregnant within the next year |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | First Hospital of Jilin University | Changchun | Jilin |
Lead Sponsor | Collaborator |
---|---|
Yi Yang |
China,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | Yes |
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