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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
Sponsor:
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
Enrollment 126
Recruitment Details 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  
Arm/Group Title Moyamoya
Hide Arm/Group Description Participants with Moyamoya disease received arterial spin label magnetic resonance imaging (MRI) with xenon contrast agent.
Period Title: Overall Study
Started 126
Completed 126
Not Completed 0
Arm/Group Title Moyamoya
Hide Arm/Group Description Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
Overall Number of Baseline Participants 126
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants
41.3  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants
Female
89
  70.6%
Male
37
  29.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 126 participants
126
1.Primary Outcome
Title Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity)
Hide Description Sensitivity and specificity for MRI-based ASL measure of presence of collaterals was measured using digital subtraction angiography as a gold standard. Measurements were for 20 regions per patient were scored as either positive or negative for collateral flow. A positive value (results) means the region is supplied by collateral flow. Negative means the region is supplied by antegrade (normal) flow. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such.
Time Frame performed one time within 1 week prior to surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant did not undergo MRI and was not included in the analysis.
Arm/Group Title Moyamoya
Hide Arm/Group Description:
Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
Overall Number of Participants Analyzed 125
Overall Number of Units Analyzed
Type of Units Analyzed: Cerebral regions
2500
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of regions
Sensitivity
81.7
(79.3 to 84.0)
Specificity
88.9
(86.6 to 90.8)
Time Frame 2 days
Adverse Event Reporting Description Observed subjects for allergic reactions or other adverse events.
 
Arm/Group Title Moyamoya
Hide Arm/Group Description Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent.
All-Cause Mortality
Moyamoya
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Moyamoya
Affected / at Risk (%)
Total   0/126 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Moyamoya
Affected / at Risk (%)
Total   0/126 (0.00%) 
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
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