Clinical trial NCT02127294: Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
Official title: Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foramen Ovale, Patent
Migraine
Keywords: Foramen Ovale, Patent
migraine
transcatheter patent foramen ovale closure
contrast-enhanced transcranial Doppler
Transthoracic Echocardiography
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine.


Eligibility criteria: 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

Primary outcomes:
measure: Contrast-enhanced Transcranial Doppler
timeFrame: within one year period
Secondary outcomes:
measure: Headache Impact Test-6
timeFrame: within one year period, at least 3 months
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Yi Yang, MD, PhD
role: STUDY_CHAIR
affiliation: The First Hospital of Jilin University
name: Yingqi Xing, MD, PhD
role: STUDY_DIRECTOR
affiliation: The First Hospital of Jilin University
name: Yuzhu Guo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.