- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00750594
Patent Foramen Ovale in Children With Migraine Headaches
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Primary Children's Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
1
|
2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The prevalence of PFO in children with migraine headaches
Time Frame: One year
|
One year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rachel McCandless, MD, University of Utah
- Study Chair: LuAnn Minich, MD, University of Utah
- Study Chair: James Bale, MD, University of Utah
Publications and helpful links
General Publications
- Stewart WF, Lipton RB, Celentano DD, Reed ML. Prevalence of migraine headache in the United States. Relation to age, income, race, and other sociodemographic factors. JAMA. 1992 Jan 1;267(1):64-9.
- Goadsby PJ, Lipton RB, Ferrari MD. Migraine--current understanding and treatment. N Engl J Med. 2002 Jan 24;346(4):257-70. doi: 10.1056/NEJMra010917. No abstract available.
- Lauritzen M. Pathophysiology of the migraine aura. The spreading depression theory. Brain. 1994 Feb;117 ( Pt 1):199-210. doi: 10.1093/brain/117.1.199.
- Olesen J, Larsen B, Lauritzen M. Focal hyperemia followed by spreading oligemia and impaired activation of rCBF in classic migraine. Ann Neurol. 1981 Apr;9(4):344-52. doi: 10.1002/ana.410090406.
- Agmon Y, Khandheria BK, Meissner I, Gentile F, Sicks JD, O'Fallon WM, Whisnant JP, Wiebers DO, Seward JB. Comparison of frequency of patent foramen ovale by transesophageal echocardiography in patients with cerebral ischemic events versus in subjects in the general population. Am J Cardiol. 2001 Aug 1;88(3):330-2. doi: 10.1016/s0002-9149(01)01656-3. No abstract available.
- Hagen PT, Scholz DG, Edwards WD. Incidence and size of patent foramen ovale during the first 10 decades of life: an autopsy study of 965 normal hearts. Mayo Clin Proc. 1984 Jan;59(1):17-20. doi: 10.1016/s0025-6196(12)60336-x.
- Del Sette M, Angeli S, Leandri M, Ferriero G, Bruzzone GL, Finocchi C, Gandolfo C. Migraine with aura and right-to-left shunt on transcranial Doppler: a case-control study. Cerebrovasc Dis. 1998 Nov-Dec;8(6):327-30. doi: 10.1159/000015875.
- Anzola GP, Magoni M, Guindani M, Rozzini L, Dalla Volta G. Potential source of cerebral embolism in migraine with aura: a transcranial Doppler study. Neurology. 1999 May 12;52(8):1622-5. doi: 10.1212/wnl.52.8.1622.
- Domitrz I, Mieszkowski J, Kaminska A. Relationship between migraine and patent foramen ovale: a study of 121 patients with migraine. Headache. 2007 Oct;47(9):1311-8. doi: 10.1111/j.1526-4610.2006.00724.x.
- Schwerzmann M, Nedeltchev K, Lagger F, Mattle HP, Windecker S, Meier B, Seiler C. Prevalence and size of directly detected patent foramen ovale in migraine with aura. Neurology. 2005 Nov 8;65(9):1415-8. doi: 10.1212/01.wnl.0000179800.73706.20. Epub 2005 Sep 7.
- Dalla Volta G, Guindani M, Zavarise P, Griffini S, Pezzini A, Padovani A. Prevalence of patent foramen ovale in a large series of patients with migraine with aura, migraine without aura and cluster headache, and relationship with clinical phenotype. J Headache Pain. 2005 Sep;6(4):328-30. doi: 10.1007/s10194-005-0223-9.
- Wilmshurst P,Dowson A,Muir K,Mullen M,Nightingale S. The prevalence and size of persistent foramen ovale in migraine patients: Preliminary results from the migraine intervention with STARFlex (R) technology (MIST) trial [abstract]. Circulation 2005; 112:3051.
- Post MC, Budts W. The relationship between migraine and right-to-left shunt: Fact or fiction? Chest. 2006 Sep;130(3):896-901. doi: 10.1378/chest.130.3.896.
- Slavin L, Tobis JM, Rangarajan K, Dao C, Krivokapich J, Liebeskind DS. Five-year experience with percutaneous closure of patent foramen ovale. Am J Cardiol. 2007 May 1;99(9):1316-20. doi: 10.1016/j.amjcard.2006.12.054. Epub 2007 Mar 20.
- Kimmelstiel C, Gange C, Thaler D. Is patent foramen ovale closure effective in reducing migraine symptoms? A controlled study. Catheter Cardiovasc Interv. 2007 Apr 1;69(5):740-6. doi: 10.1002/ccd.21025.
- Schwerzmann M, Wiher S, Nedeltchev K, Mattle HP, Wahl A, Seiler C, Meier B, Windecker S. Percutaneous closure of patent foramen ovale reduces the frequency of migraine attacks. Neurology. 2004 Apr 27;62(8):1399-401. doi: 10.1212/01.wnl.0000120677.64217.a9.
- Shammas NW, Dippel EJ, Harb G, Egts S, Jerin M, Stoakes P, Byrd J, Shammas GA, Sharis P. Interatrial septal defect closure for prevention of cerebrovascular accidents: impact on recurrence and frequency of migraine headaches. J Invasive Cardiol. 2007 Jun;19(6):257-60.
- Anzola GP, Frisoni GB, Morandi E, Casilli F, Onorato E. Shunt-associated migraine responds favorably to atrial septal repair: a case-control study. Stroke. 2006 Feb;37(2):430-4. doi: 10.1161/01.STR.0000199082.07317.43. Epub 2005 Dec 22.
- Thanigaraj S, Valika A, Zajarias A, Lasala JM, Perez JE. Comparison of transthoracic versus transesophageal echocardiography for detection of right-to-left atrial shunting using agitated saline contrast. Am J Cardiol. 2005 Oct 1;96(7):1007-10. doi: 10.1016/j.amjcard.2005.05.061.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Congenital Abnormalities
- Headache Disorders, Primary
- Headache Disorders
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Heart Septal Defects, Atrial
- Heart Septal Defects
- Migraine Disorders
- Headache
- Foramen Ovale, Patent
Other Study ID Numbers
- 00026512
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine Headaches
-
Gazi UniversityRecruitingHeadache | Headache Disorders | Headache, Migraine | Headaches Chronic | Headache, Tension | Headaches MuscularTurkey
-
University of Notre Dame AustraliaUnknown
-
Memorial Medical CenterUnited States Department of DefenseCompletedMigraine HeadachesUnited States
-
University of North Carolina, Chapel HillNational Center for Complementary and Integrative Health (NCCIH)Completed
-
Gazi UniversityRecruitingHeadache | Headache Disorders | Headache, Migraine | Headaches Chronic | Headache, Tension | Headaches MuscularTurkey
-
POZENCompletedMigraine HeadachesUnited States
-
University of SaskatchewanSaskatchewan Health Research FoundationCompleted
-
University of Texas Southwestern Medical CenterMerck Sharp & Dohme LLCCompleted
-
SK Life Science, Inc.CompletedMigraine HeadachesUnited States
-
POZENCompletedMigraine HeadachesUnited States