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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
Sponsor:
Collaborators:
University of Washington
Coherex Medical
The John L. Locke, Jr. Charitable Trust
National Headache Foundation
Information provided by (Responsible Party):
Swedish Medical Center

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Cross-Sectional
Conditions Migraine With Aura
Patent Foramen Ovale
Enrollment 31
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
Hide Arm/Group Description 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
Arm/Group Title Control (Absence of PFO) Large PFO Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 19 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
19
 100.0%
31
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 12 participants 19 participants 31 participants
Female
11
  91.7%
16
  84.2%
27
  87.1%
Male
1
   8.3%
3
  15.8%
4
  12.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 19 participants 31 participants
12 19 31
1.Primary Outcome
Title Embolic Tracks
Hide Description Embolic tracks on transcranial Doppler at rest and following calibrated Valsalva maneuver
Time Frame Baseline
Outcome Measure Data Not Reported
2.Primary Outcome
Title Cerebral Vasomotor Reactivity (VMR)
Hide Description

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

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control (Absence of PFO) Large PFO
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 12 19
Mean (Standard Deviation)
Unit of Measure: Percentage change
89  (20) 97  (24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control (Absence of PFO), Large PFO
Comments Mann-Whitney U test was used to test the null hypothesis that basilar artery vasomotor reactivity was equivalent between the two groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Platelet Activation
Hide Description Platelet-poor plasma levels of sCD40L and P-selectin, and serum concentration of TXB2.
Time Frame Baseline
Outcome Measure Data Not Reported
4.Primary Outcome
Title Sleep Apnea, Number of Participants
Hide Description 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.
Time Frame Following one night of a home sleep study
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on per protocol.
Arm/Group Title Control (Absence of PFO) Large PFO
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11 16
Measure Type: Number
Unit of Measure: participants
0 1
5.Primary Outcome
Title Cognitive Function
Hide Description Cognitive function will be assessed by a battery of performance-based neuropsychological tests.
Time Frame Baseline
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Oxygen Desaturation Index
Hide Description Measurement of number of times per hour blood oxygen saturation decreases by at least 4% during home sleep study.
Time Frame Baseline
Outcome Measure Data Not Reported
7.Secondary Outcome
Title White Matter Lesions
Hide Description Presence and severity of white matter lesions on magnetic resonance imaging, taken within 5 years prior to study enrollment. Subjects will not have magnetic resonance imaging performed as part of this study. Films will be requested and an independent neuroradiologist will assess presence of white matter lesions.
Time Frame Within 5 years prior to enrollment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control (Absence of PFO) Large PFO
Hide Arm/Group Description 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.
All-Cause Mortality
Control (Absence of PFO) Large PFO
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control (Absence of PFO) Large PFO
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control (Absence of PFO) Large PFO
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/19 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jill T. Jesurum, Ph.D.
Organization: Swedish Medical Center
Phone: 206-683-1505
Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT01257880     History of Changes
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