Status:
COMPLETED
Comorbidities Associated With Migraine and Patent Foramen Ovale (CAMP)
Lead Sponsor:
Swedish Medical Center
Collaborating Sponsors:
University of Washington
Coherex Medical
Conditions:
Migraine With Aura
Patent Foramen Ovale
Eligibility:
All Genders
18-55 years
Brief 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...
Detailed Description
A two-group observational study will be performed to determine if comorbidities associated with MA are more prevalent in the setting of large PFO. Potential subjects will be screened to assure that in...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01257880
Start Date
January 1 2010
End Date
May 1 2011
Last Update
September 27 2011
Active Locations (2)
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1
Swedish Medical Center
Seattle, Washington, United States, 98122
2
The University of Washington
Seattle, Washington, United States, 98195