Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Patent Foramen Ovale in Children With Migraine Headaches

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. Identifier: NCT00750594
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : December 26, 2017
Primary Children's Hospital
Information provided by (Responsible Party):
University of Utah

Brief Summary:
This study will be the first to provide data about the relationship between PFO and migraine in children. By establishing the actual prevalence, we will better understand if PFO plays a role in the occurence of pediatric migraine and, thus, provide the incentive to perform additional studies evaluating whether PFO closure is an effective treatment option for pediatric migraine. For children with migraine headaches, discovering novel and effective treatments would be life altering.

Condition or disease
Migraine Headaches

Detailed Description:

Specific Aim 1 Using contrast transthoracic echocardiography, compare the prevalence of a PFO in children with migraine headache with the established incidence of PFO published for the general population.

Specific Aim 2 Using contrast transcranial Doppler, examine the relationship between the degree of right to left atrial shunting with the presence or absence of aura in children with migraine.

Layout table for study information
Study Type : Observational
Actual Enrollment : 109 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Patent Foramen Ovale in Children With Migraine Headaches
Study Start Date : April 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine


Primary Outcome Measures :
  1. The prevalence of PFO in children with migraine headaches [ Time Frame: One year ]

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:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric neurology clinic

Inclusion Criteria:

  • Greater than or equal to six years of age and less than 18 years of age.
  • Diagnosis of migraine headache based on the International Headache Society Criteria.
  • English speaking patients (and parent/guardians where appropriate).
  • Signed informed consent/assent (as appropriate) given by patient, parent or legal guardian.

Exclusion Criteria:

  • Inability to cooperate with imaging studies.
  • Known congenital heart disease.
  • Parent or guardian is unwilling to have their child undergo contrast echocardiography.

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 identifier (NCT number): NCT00750594

Layout table for location information
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Primary Children's Hospital
Layout table for investigator information
Principal Investigator: Rachel McCandless, MD University of Utah
Study Chair: LuAnn Minich, MD University of Utah
Study Chair: James Bale, MD University of Utah
Publications of Results:
Wilmshurst P,Dowson A,Muir K,Mullen M,Nightingale S. The prevalence and size of persistent foramen ovale in migraine patients: Preliminary results from the migraine intervention with STARFlex (R) technology (MIST) trial [abstract]. Circulation 2005; 112:3051.

Layout table for additonal information
Responsible Party: University of Utah Identifier: NCT00750594    
Other Study ID Numbers: 00026512
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Keywords provided by University of Utah:
Migraine headaches
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
Neurologic Manifestations
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities