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Patent Foramen Ovale in Children With Migraine Headaches

Utah System of Higher Education (USHE) logo

Utah System of Higher Education (USHE)

Status

Completed

Conditions

Migraine Headaches

Study type

Observational

Funder types

Other

Identifiers

NCT00750594
00026512

Details and patient eligibility

About

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.

Full 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.

Enrollment

109 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

109 participants in 2 patient groups

1
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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