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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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.

Reporting Groups
  Description
Control (Absence of PFO) Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
Large PFO Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.

Participant Flow:   Overall Study
    Control (Absence of PFO)   Large PFO
STARTED   12   19 
COMPLETED   12   19 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control (Absence of PFO) Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
Large PFO Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
Total Total of all reporting groups

Baseline Measures
   Control (Absence of PFO)   Large PFO   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 12   19   31 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   12   19   31 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 37  (10)   35  (11)   35  (11) 
Gender 
[Units: Participants]
 		     
Female   11   16   27 
Male   1   3   4 
Region of Enrollment 
[Units: Participants]
 		     
United States   12   19   31 


  Outcome Measures

1.  Primary:   Cerebral Vasomotor Reactivity (VMR)   [ Time Frame: Baseline ]
  Show Outcome Measure 1

2.  Primary:   Sleep Apnea, Number of Participants   [ Time Frame: Following one night of a home sleep study ]
  Show Outcome Measure 2

3.  Primary:   Embolic Tracks   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Primary:   Platelet Activation   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Primary:   Cognitive Function   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Oxygen Desaturation Index   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   White Matter Lesions   [ Time Frame: Within 5 years prior to enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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
e-mail: jill.jesurum@swedish.org



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