Patent Foramen Ovale in Children With Migraine Headaches

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00750594

Enrollment

109

Registered

2008-09-10

Start date

2008-04-30

Completion date

2011-03-31

Last updated

2017-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Headaches

Keywords

Children, Migraine headaches

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

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.

Design outcomes

Primary

Measure	Time frame
The prevalence of PFO in children with migraine headaches	One year

Countries

United States

Outcome results