Patent Foramen Ovale in Children With Migraine Headaches

NCT00750594 | Completed

• 1 other identifier: 00026512
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Headaches

Keywords

Children; Migraine headaches

Outcome Measures

Primary Outcomes (1)

• The prevalence of PFO in children with migraine headaches

  One year

Study Arms (2)

1

2

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

pediatric neurology clinic

You may qualify if:

• 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.

You may not qualify if:

• Inability to cooperate with imaging studies.
• Known congenital heart disease.
• Parent or guardian is unwilling to have their child undergo contrast echocardiography.

Sponsors & Collaborators

• University of Utah: lead
• Primary Children's Hospital: collaborator

Study Sites (1)

Primary Children's Medical Center

Salt Lake City, Utah, 84112, United States

Location

Related Publications (19)

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  PMID: 1727198 RESULT

• 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.

  PMID: 11807151 RESULT

• 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.

  PMID: 7908596 RESULT

• 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.

  PMID: 6784664 RESULT

• 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.

  PMID: 11472723 RESULT

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  PMID: 6694427 RESULT

• 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.

  PMID: 9774749 RESULT

• 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.

  PMID: 10331688 RESULT

• 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.

  PMID: 17927647 RESULT

• 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.

  PMID: 16148260 RESULT

• 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.

  PMID: 16362702 RESULT

• 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.

  RESULT

• 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.

  PMID: 16963692 RESULT

• 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.

  PMID: 17478165 RESULT

• 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.

  PMID: 17295330 RESULT

• 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.

  PMID: 15111681 RESULT

• 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.

  PMID: 17541126 RESULT

• 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.

  PMID: 16373630 RESULT

• 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.

  PMID: 16188533 RESULT

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Rachel McCandless, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

• LuAnn Minich, MD

  University of Utah

  STUDY CHAIR

• James Bale, MD

  University of Utah

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 10, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 26, 2017

Record last verified: 2017-12

Locations

US (1)