Comorbidities Associated With Migraine and Patent Foramen Ovale (CAMP)

Completed

Conditions studied: Migraine With Aura, Patent Foramen Ovale

In brief

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.

Key facts

Study ID

NCT01257880

Run by

Swedish Medical Center

People needed

31

Starts

2010-01-01

Expected to finish

2011-05-01

Last updated by the study team

2011-09-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-55 years
• Ability to speak, read, and understand English
• Documented diagnosis of migraine aura (MA) for a ≥2 year period preceding enrollment, confirmed by a neurology healthcare provider (MD, DO, ARNP, PA-C) using the International Classification of Headache Disorders criteria. Focal neurologic symptoms must precede or accompany the headache (aura) for at least one headache in the 12 months prior to enrollment.
• Average of 4 to 14 migraine days per month for the 3-month period preceding enrollment
• Migraine prevention regimen stable for at least 30 days prior to enrollment. This criterion does not pertain to acute medications or aspirin- or non-steroidal anti-inflammatory (NSAID)- containing medications, which will be held (wash-out) prior to blood draw. See below.
• Able and willing to complete a washout of aspirin, NSAIDs (including ibuprofen, naproxen sodium, ketorolac), combination drugs containing these compounds, or dietary supplements containing willow bark (salicylate) prior to blood collection.
• Experimental group: Documented large right-to-left shunt (RLS) with >100 embolic tracks (ET) at rest or following calibrated or uncalibrated respiratory strain by TCD (whichever yields largest number of ET).
• Control group: Documented absence of right-to-left shunt (RLS) with <11 ET at rest and following calibrated and uncalibrated respiratory strain by TCD (whichever yields largest number of ET).
• Adequate correction of hearing and/or vision deficits

You may not qualify if…

• Pregnancy
• Postmenopausal female
• Documented right-to-left shunt (RLS) with 11 to 100 ET at rest or following calibrated or uncalibrated respiratory strain by TCD (whichever yields largest number of ET)
• History of stroke or neurological condition associated with cognitive dysfunction such as multiple sclerosis, epilepsy, brain tumor or brain injury
• Chronic migraine or medication overuse headache
• Prescription use of warfarin or antiplatelet drug such as clopidogrel or aspirin
• Inability or unwillingness to complete a washout of aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), combination drugs containing these compounds, or dietary supplements containing willow bark (salicylate)
• Evidence of carotid, vertebral, or basilar artery stenosis >50% on duplex imaging
• Evidence of fetal origins or >50% stenosis of intracranial blood vessels on TCD imaging
• Inadequate temporal bone windows (signals) for TCD insonation
• Daily treatment regimen includes topiramate and/or other medication that causes significant cognitive or psychomotor impairment based on provider assessment and/or self-report (e.g., amitryptiline, divalproex sodium)
• Use of continuous positive-airway pressure (CPAP) instrumentation within 6 months of study enrollment
• Status post PFO or RLS closure/repair
• Beck Depression Inventory score ≥29
• State-Trait Anxiety Inventory score exceeding cutoff for age and sex

Where it is running

• Swedish Medical Center — Seattle, Washington, United States
• The University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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