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Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients

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ClinicalTrials.gov Identifier: NCT01419275
Recruitment Status : Completed
First Posted : August 18, 2011
Results First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Information provided by (Responsible Party):
Greg Zaharchuk, Stanford University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Cerebrovascular Accident
Moyamoya Disease
Interventions: Drug: Xenon contrast agent
Device: Magnetic Resonance Imaging

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment was closed prior to any enrollment in the acute stroke, healthy participant, and diagnosis unspecified groups, so results are presented for the Moyamoya group only.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Moyamoya Participants with Moyamoya disease received arterial spin label magnetic resonance imaging (MRI) with xenon contrast agent.

Participant Flow:   Overall Study
STARTED   126 

  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.
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Reporting Groups
Moyamoya Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 41.3  (11.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      89  70.6% 
Male      37  29.4% 
Region of Enrollment 
[Units: Participants]
United States   126 

  Outcome Measures

1.  Primary:   Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity)   [ Time Frame: performed one time within 1 week prior to surgery ]

  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Greg Zaharchuk
Organization: Stanford University
phone: 650-736-6172
e-mail: susanmir@stanford.edu

Responsible Party: Greg Zaharchuk, Stanford University
ClinicalTrials.gov Identifier: NCT01419275     History of Changes
Other Study ID Numbers: SU-06152011-7929
First Submitted: August 16, 2011
First Posted: August 18, 2011
Results First Submitted: December 21, 2016
Results First Posted: August 30, 2017
Last Update Posted: August 30, 2017