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Sponsors and Collaborators: |
University of Utah Primary Children's Medical Center Foundation |
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Information provided by: | University of Utah |
ClinicalTrials.gov Identifier: | NCT00750594 |
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 |
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Migraine Headaches |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | Patent Foramen Ovale in Children With Migraine Headaches |
Estimated Enrollment: | 100 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1 |
2 |
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.
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
pediatric neurology clinic
Inclusion Criteria:
Exclusion Criteria:
United States, Utah | |
Primary Children's Medical Center | |
Salt Lake City, Utah, United States, 84112 |
Principal Investigator: | Rachel McCandless, MD | University of Utah |
Study Chair: | LuAnn Minich, MD | University of Utah |
Study Chair: | James Bale, MD | University of Utah |
Responsible Party: | University of Utah ( Rachel McCandless, MD ) |
Study ID Numbers: | 00026512 |
Study First Received: | September 9, 2008 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00750594 History of Changes |
Health Authority: | United States: Institutional Review Board |
Children Migraine headaches |
Heart Septal Defects Heart Diseases Cardiovascular Abnormalities Central Nervous System Diseases Headache Disorders, Primary Pain Brain Diseases Heart Septal Defects, Atrial Headache Disorders |
Signs and Symptoms Migraine Disorders Foramen Ovale, Patent Headache Neurologic Manifestations Congenital Heart Septum Defect Congenital Abnormalities Heart Defects, Congenital |
Heart Septal Defects Heart Diseases Cardiovascular Abnormalities Nervous System Diseases Central Nervous System Diseases Headache Disorders, Primary Pain Brain Diseases Heart Septal Defects, Atrial |
Headache Disorders Signs and Symptoms Foramen Ovale, Patent Migraine Disorders Headache Neurologic Manifestations Cardiovascular Diseases Congenital Abnormalities Heart Defects, Congenital |