Comorbidities Associated With Migraine and Patent Foramen Ovale (CAMP) (CAMP)
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ClinicalTrials.gov Identifier: NCT01257880 |
Recruitment Status :
Completed
First Posted : December 10, 2010
Results First Posted : September 21, 2011
Last Update Posted : September 27, 2011
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Sponsor:
Swedish Medical Center
Collaborators:
University of Washington
Coherex Medical
The John L. Locke, Jr. Charitable Trust
National Headache Foundation
Information provided by (Responsible Party):
Swedish Medical Center
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Study Type | Observational |
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Study Design | Observational Model: Case-Control; Time Perspective: Cross-Sectional |
Conditions |
Migraine With Aura Patent Foramen Ovale |
Enrollment | 31 |
Participant Flow
Recruitment Details | Over a 20-month period (January 2010 to May 2011), 127 subjects were screened and 31 were enrolled from Swedish Medical Center and the University of Washington Medical Center, including 19 with MA + PFO and 12 with MA - PFO. |
Pre-assignment Details |
Of 127 potential subjects screened, reasons for exclusion included the following: 22 (17%) chronic migraine or medication overuse headache; 9 (7%) topiramate use; 6 (5%) stroke or multiple sclerosis; 39 (31%) other (declined, low frequency); 12 (9%) small to medium sized PFO; 8 (6%) fetal origins. |
Arm/Group Title | Control (Absence of PFO) | Large PFO |
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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. |
Period Title: Overall Study | ||
Started | 12 | 19 |
Completed | 12 | 19 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Control (Absence of PFO) | Large PFO | Total | |
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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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 12 | 19 | 31 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 19 participants | 31 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
12 100.0%
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19 100.0%
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31 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 12 participants | 19 participants | 31 participants | |
37 (10) | 35 (11) | 35 (11) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 19 participants | 31 participants | |
Female |
11 91.7%
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16 84.2%
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27 87.1%
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Male |
1 8.3%
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3 15.8%
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4 12.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 12 participants | 19 participants | 31 participants |
12 | 19 | 31 |
Outcome Measures
Adverse Events
Limitations and Caveats
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.
More Information
Results Point of Contact
Name/Title: | Jill T. Jesurum, Ph.D. |
Organization: | Swedish Medical Center |
Phone: | 206-683-1505 |
EMail: | jill.jesurum@swedish.org |
Responsible Party: | Swedish Medical Center |
ClinicalTrials.gov Identifier: | NCT01257880 |
Other Study ID Numbers: |
4865S-09 |
First Submitted: | December 8, 2010 |
First Posted: | December 10, 2010 |
Results First Submitted: | July 20, 2011 |
Results First Posted: | September 21, 2011 |
Last Update Posted: | September 27, 2011 |