Comorbidities Associated With Migraine and Patent Foramen Ovale (CAMP) (CAMP)

• 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: 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

• Study Type: Observational
• 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
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

Baseline Characteristics

Arm/Group Title		Control (Absence of PFO)	Large PFO	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Embolic Tracks
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control (Absence of PFO)	Large PFO
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)

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
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
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

Outcome Measure Data

Analysis Population Description

The analysis was based on per protocol.

Arm/Group Title	Control (Absence of PFO)	Large PFO
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
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
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
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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Control (Absence of PFO)	Large PFO
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	--/--	--/--
Serious Adverse Events
	Control (Absence of PFO)	Large PFO
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/12 (0.00%)	0/19 (0.00%)
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%)

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

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
• 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