Migraine HeadachesNCT00750594
Patent Foramen Ovale in Children With Migraine Headaches
An observational study of Migraine Headaches, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Migraine Headaches
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric neurology clinic
Who may be able to join
- 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.
Who cannot join
- Inability to cooperate with imaging studies.
- Known congenital heart disease.
- Parent or guardian is unwilling to have their child undergo contrast echocardiography.
Trial locations and contacts
1 site in 1 country.
United States1 site
Primary Children's Medical Center
Salt Lake City, Utah, 84112
About this study
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.
Read the 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.
- Conditions
- Migraine Headaches
- Keywords
- Children, Migraine headaches
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of PFO in children with migraine headaches
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Migraine HeadachesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Primary Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Rachel McCandless, MD, Principal investigator, University of UtahLuAnn Minich, MD, Study chair, University of UtahJames Bale, MD, Study chair, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750594
- Sponsor's protocol ID
- 00026512
- Status last verified
- Dec 2017
- First submitted
- 9 Sep 2008
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 1727198Goadsby 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.
PubMed 11807151Lauritzen 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.
PubMed 7908596Olesen 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.
PubMed 6784664Agmon 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.
PubMed 11472723Hagen 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.
PubMed 6694427Del 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.
PubMed 9774749Anzola 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.
PubMed 10331688Domitrz 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.
PubMed 17927647Schwerzmann 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.
PubMed 16148260Dalla 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.
PubMed 16362702Wilmshurst 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.
PubMed 16963692Slavin 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.
PubMed 17478165Kimmelstiel 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.
PubMed 17295330
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patent Foramen Ovale in Children With Migraine Headaches
- ClinicalTrials.gov ID
- NCT00750594
- Acronym / sponsor ID
- 00026512
- Conditions
- Migraine Headaches
- Keywords
- Children, Migraine headaches
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Primary Children's Hospital
- Study start
- Apr 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric neurology clinic
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Inability to cooperate with imaging studies.
- Known congenital heart disease.
- Parent or guardian is unwilling to have their child undergo contrast echocardiography.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of PFO in children with migraine headaches
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Results publication: PubMed 1727198Stewart 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.
- Results publication: PubMed 11807151Goadsby 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.
- Results publication: PubMed 7908596Lauritzen 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.
- Results publication: PubMed 6784664Olesen 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.
- Results publication: PubMed 11472723Agmon 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.
- Results publication: PubMed 6694427Hagen 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.
- Results publication: PubMed 9774749Del 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.
- Results publication: PubMed 10331688Anzola 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.
- Results publication: PubMed 17927647Domitrz 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.
- Results publication: PubMed 16148260Schwerzmann 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.
- Results publication: PubMed 16362702Dalla 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.
- Results publicationWilmshurst 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel McCandless, MD principal investigator
University of Utah
LuAnn Minich, MD study chair
University of Utah
James Bale, MD study chair
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Headaches, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of PFO in children with migraine headaches (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00750594, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.