Clinical trial NCT00750594: Patent Foramen Ovale in Children With Migraine Headaches
Official title: Patent Foramen Ovale in Children With Migraine Headaches
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Headaches
Keywords: Children
Migraine headaches
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Primary Children's Hospital
First posted: 2008-09-10
Enrollment: 109
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric neurology clinic

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.

Eligibility 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.

Primary outcomes:
measure: The prevalence of PFO in children with migraine headaches
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
Study officials:
affiliation: University of Utah
name: Rachel McCandless, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: LuAnn Minich, MD
role: STUDY_CHAIR
affiliation: University of Utah
name: James Bale, MD
role: STUDY_CHAIR
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