NCT02127294

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

2.4 years

First QC Date

April 29, 2014

Last Update Submit

January 12, 2016

Conditions

Foramen Ovale, PatentMigraine

Keywords

Foramen Ovale, Patentmigrainetranscatheter patent foramen ovale closurecontrast-enhanced transcranial DopplerTransthoracic Echocardiography

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Headache Impact Test-6

    within one year period, at least 3 months

Study Arms (2)

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.

Device: transcatheter patent foreman ovale closure

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.

Interventions

transcatheter patent foreman ovale closureDEVICE
Transcatheter closure group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Transcatheter closure group: Closure of PFO is performed

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Related Publications (2)

  • 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.

    PMID: 22747847BACKGROUND

  • 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.

    PMID: 27966652DERIVED

MeSH Terms

Conditions

Foramen Ovale, PatentMigraine Disorders

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated Dean of First Hospital of Jilin University

Study Record Dates

First Submitted

April 29, 2014

First Posted

April 30, 2014

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

January 1, 2016

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

CN(1)