Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02127294
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Yi Yang, First Hospital of Jilin University

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

Condition or disease Intervention/treatment Phase
Foramen Ovale, Patent Migraine Device: transcatheter patent foreman ovale closure Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
Study Start Date : January 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

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.
Device: transcatheter patent foreman ovale closure
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127294


Locations
Layout table for location information
China, Jilin
First Hospital of Jilin University
Changchun, Jilin, China, 130000
Sponsors and Collaborators
Yi Yang
Investigators
Layout table for investigator information
Study Chair: Yi Yang, MD, PhD First Hospital of Jilin University
Study Director: Yingqi Xing, MD, PhD First Hospital of Jilin University
Principal Investigator: Yuzhu Guo First Hospital of Jilin University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Yi Yang, Associated Dean of First Hospital of Jilin University, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT02127294    
Other Study ID Numbers: PFO-1shsf
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Keywords provided by Yi Yang, First Hospital of Jilin University:
Foramen Ovale, Patent
migraine
transcatheter patent foramen ovale closure
contrast-enhanced transcranial Doppler
Transthoracic Echocardiography
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Foramen Ovale, Patent
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities