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CAMP
Sponsor study identifier
observational
31
1 country
2
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
December 8, 2010
Actual (reported)December 10, 2010
Actual (reported)May 2011
Actual (reported)May 2011
Actual (reported)September 21, 2011
Actual (reported)Embolic Tracks
Embolic tracks on transcranial Doppler at rest and following calibrated Valsalva maneuver
Baseline
Cerebral Vasomotor Reactivity (VMR)
The percentage change in basilar artery blood flow velocity from baseline between hypercapnia (increased blood CO2) and hypocapnia (decreased blood CO2), as measured by transcranial Doppler during a single testing period. This is calculated using the following equation: VMR = 100 x (VelocityHYPERCAPNIA - VelocityHYPOCAPNIA) / VelocityBASELINE
Baseline
Platelet Activation
Platelet-poor plasma levels of sCD40L and P-selectin, and serum concentration of TXB2.
Baseline
Sleep Apnea, Number of Participants
An apnea-hypopnea index (AHI) \>10 per hour during a home sleep study, defined as at least 5 hours of recorded data on the portable sleep monitor instrument for either the apnea-hypopnea index (AHI) or oxygen desaturation index (ODI) and at least 3 hours for the other index. The scale adopted for assessment of sleep apnea is as follows: AHI \< 5, optimal; AHI 5-10, equivocal, participant may have sleep apnea; AHI \>10, sleep apnea highly likely.
Oxygen Desaturation Index
Baseline
White Matter Lesions
Within 5 years prior to enrollment
Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
Otherwise healthy persons who have a diagnosis of MA, based on the International Classification of Headache Disorders Diagnostic Criteria, will be recruited from headache and neurology clinics. Potential subjects can self refer if they have a diagnosis of MA.
Swedish Medical Center
Seattle, Washington, 98122, United States
The University of Washington
Seattle, Washington, 98195, United States
Subjects were recruited from a headache clinic and had a high degree of migraine burden; thus, the sample may not accurately represent the general migraine population. The number of men in the sample was insufficient to test sex differences.
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
31 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2010
First Posted
December 10, 2010
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Following one night of a home sleep study
Cognitive Function
Cognitive function will be assessed by a battery of performance-based neuropsychological tests.
Baseline
Contact the study team to confirm eligibility.
Alan M. Haltiner, Ph.D.
Swedish Medical Center
Colleen M. Douville, B.S.
Swedish Medical Center
Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
September 27, 2011
Results First Posted
September 21, 2011
Record last verified: 2011-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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