- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02127294
Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine (EASTFORM)
January 12, 2016 updated by: Yi Yang
The purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
258
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jilin
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Changchun, Jilin, China, 130000
- First Hospital of Jilin University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transcatheter closure group
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.
|
|
No Intervention: Contrast group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contrast-enhanced Transcranial Doppler
Time Frame: within one year period
|
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.
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within one year period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Headache Impact Test-6
Time Frame: within one year period, at least 3 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yi Yang, MD, PhD, The first hospital of Jilin University
- Study Director: Yingqi Xing, MD, PhD, The first hospital of Jilin University
- Principal Investigator: Yuzhu Guo, The first hospital of Jilin University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
April 29, 2014
First Submitted That Met QC Criteria
April 29, 2014
First Posted (Estimate)
April 30, 2014
Study Record Updates
Last Update Posted (Estimate)
January 13, 2016
Last Update Submitted That Met QC Criteria
January 12, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Congenital Abnormalities
- Headache Disorders, Primary
- Headache Disorders
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Heart Septal Defects, Atrial
- Heart Septal Defects
- Migraine Disorders
- Foramen Ovale, Patent
Other Study ID Numbers
- PFO-1shsf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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