Patent Foramen Ovale in Children With Migraine Headaches | NCT00750594

Studies
Patent Foramen Ovale in Children With Migraine Headaches

NCT00750594

Sponsor

University of Utah

Status

Completed

Last Update Posted

Dec 26, 2017Actual

Enrollment

109Actual

Phase

Not provided

Conditions

Migraine Headaches

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Sep 9, 2008

First Submission Date that Met QC Criteria

Sep 9, 2008

First Posted Date

Sep 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2017

Last Update Posted Date

Dec 26, 2017Actual

Name	Class
Primary Children's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

109Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

pediatric neurology clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachel McCandless, MD	University of Utah	Principal Investigator
LuAnn Minich, MD	University of Utah	Study Chair
James Bale, MD	University of Utah	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Primary Children's Medical Center		Salt Lake City	Utah	84112	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1727198	Result	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.
11807151	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.

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases