Patent Foramen Ovale in Children With Migraine Headaches

This study has been completed.
Sponsor:
Collaborator:
Primary Children's Hospital
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00750594
First received: September 9, 2008
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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
Migraine Headaches

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Patent Foramen Ovale in Children With Migraine Headaches

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • The prevalence of PFO in children with migraine headaches [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: April 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

pediatric neurology clinic

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750594

Locations
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
Investigators
Principal Investigator: Rachel McCandless, MD University of Utah
Study Chair: LuAnn Minich, MD University of Utah
Study Chair: James Bale, MD University of Utah
  More Information

Publications:
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.

Responsible Party: Rachel McCandless, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00750594     History of Changes
Other Study ID Numbers: 00026512
Study First Received: September 9, 2008
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Children
Migraine headaches

Additional relevant MeSH terms:
Foramen Ovale, Patent
Headache
Migraine Disorders
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 14, 2014