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Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine (EASTFORM)

Primary Purpose

Foramen Ovale, Patent, Migraine

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcatheter patent foreman ovale closure
Sponsored by
Yi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foramen Ovale, Patent focused on measuring Foramen Ovale, Patent, migraine, transcatheter patent foramen ovale closure, contrast-enhanced transcranial Doppler, Transthoracic Echocardiography

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transcatheter closure group

Contrast group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 29, 2014
Last Updated
January 12, 2016
Sponsor
Yi Yang
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1. Study Identification

Unique Protocol Identification Number
NCT02127294
Brief Title
Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
Acronym
EASTFORM
Official Title
Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yi Yang

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foramen Ovale, Patent, Migraine
Keywords
Foramen Ovale, Patent, migraine, transcatheter patent foramen ovale closure, contrast-enhanced transcranial Doppler, Transthoracic Echocardiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter closure group
Arm Type
Experimental
Arm Description
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.
Arm Title
Contrast group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
transcatheter patent foreman ovale closure
Primary Outcome Measure Information:
Title
Contrast-enhanced Transcranial Doppler
Description
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.
Time Frame
within one year period
Secondary Outcome Measure Information:
Title
Headache Impact Test-6
Description
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.
Time Frame
within one year period, at least 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Yang, MD, PhD
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yingqi Xing, MD, PhD
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yuzhu Guo
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22747847
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.
Results Reference
background
PubMed Identifier
27966652
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.
Results Reference
derived

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Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine

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