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Patent Foramen Ovale in Children With Migraine Headaches

Completed
Conditions
Migraine Headaches
Registration Number
NCT00750594
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
109
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The prevalence of PFO in children with migraine headachesOne year
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Primary Children's Medical Center

🇺🇸

Salt Lake City, Utah, United States

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