Comorbidities Associated With Migraine and Patent Foramen Ovale (CAMP)

NCT01257880 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2011-09-27

Study results available
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Summary

The purpose of the study is to compare the rate of comorbidities associated with migraine aura (MA) between persons who have a large circulatory right-to-left shunt (RLS) and those who do not have RLS.

Approximately 50% of individuals who have MA also have RLS due to patent foramen ovale (PFO). A PFO is an anatomical opening or flap between the upper chambers of the heart or atria that permits blood to pass from the right of the heart to the left side of the heart, without first going to the lungs to be filtered and oxygenated. Many health conditions and clinical syndromes including stroke, sleep apnea, and migraine have been linked to PFO. Although the mechanism is undetermined, it is hypothesized that microscopic blood clots and chemicals such as serotonin can pass through the PFO, travel to the brain, and cause headache and aura.

Persons who have MA are at increased risk for stroke and transient ischemic attacks relative to people who do not have migraine. Migraine is also associated with the presence of white matter lesions in the brain and mild deficits in cognitive function associated with the posterior brain (vision, memory, processing speed). The risk of stroke in migraine is highest for women under the age of 45 who have aura and a high number of migraine headache days per month. No convincing evidence has been produced to explain the mechanism for the increased risk of ischemic stroke in migraine; however, increased platelet activation and aggregation is a plausible theory.

We hypothesize that migraineurs with aura and large RLS (presumably due to a PFO) will be more likely to have sleep apnea, increased platelet activation, cognitive deficits, alterations in cerebral vasomotor function, and white matter lesions than migraineurs with aura who do not have PFO. The results of this exploratory study will generate hypotheses as to why subgroups of migraineurs have an increased risk of stroke and the impact of large PFO on comorbid conditions associated with migraine aura. Early identification of migraine subgroups with a constellation of clinical syndromes that increase risk of neurovascular diseases will allow initiation of preventive strategies that may ultimately reduce burden and improve the productive quality of life for these individuals.

Conditions

  • Migraine With Aura
  • Patent Foramen Ovale

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER
  • Coherex Medical

    collaborator INDUSTRY
  • The John L. Locke, Jr. Charitable Trust

    collaborator UNKNOWN
  • National Headache Foundation

    collaborator UNKNOWN
  • Swedish Medical Center

    lead OTHER

Principal Investigators

  • Jill T. Jesurum, Ph.D. · Swedish Medical Center

  • Cindy J. Fuller, Ph.D. · Swedish Medical Center

  • Sylvia M. Lucas, M.D., Ph.D. · University of Washington

  • Natalia Murinova, M.D. · University of Washington

  • Alan M. Haltiner, Ph.D. · Swedish Medical Center

  • Colleen M. Douville, B.S. · Swedish Medical Center

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01257880 on ClinicalTrials.gov