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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 16, 2011
First Posted Date  ICMJE August 18, 2011
Results First Submitted Date  ICMJE December 21, 2016
Results First Posted Date  ICMJE August 30, 2017
Last Update Posted Date August 30, 2017
Study Start Date  ICMJE April 2009
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2017)
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 ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
Official Title  ICMJE Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
Brief Summary Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients
Detailed Description In the early hours following large vessel occlusion, the ultimate severity of the stroke is largely determined by the ability of collateral flow networks to supply blood to ischemic tissue via circuitous routes that bypass the proximal clot. Robust collateral flow can improve response to thrombolytic therapy and decrease the risk of intracranial hemorrhage. Despite their central importance, collaterals during acute stroke are poorly understood, largely because assessment has required an invasive imaging test, cerebral angiography. This proposal assesses whether a noncontrast MRI perfusion technique, called arterial spin labeling (ASL), can yield important information about collateral flow.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cerebrovascular Accident
  • Moyamoya Disease
Intervention  ICMJE
  • Drug: Xenon contrast agent
    Other Name: XeMED contrast agent
  • Device: Magnetic Resonance Imaging
    Arterial spin label sequence for the purpose of measuring collateral flow
Study Arms  ICMJE
  • Experimental: Moyamoya
    Approximately 60 Moyamoya patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
    Interventions:
    • Drug: Xenon contrast agent
    • Device: Magnetic Resonance Imaging
  • Experimental: Acute stroke
    Approximately 60 acute stroke patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
    Interventions:
    • Drug: Xenon contrast agent
    • Device: Magnetic Resonance Imaging
  • Experimental: Healthy participants
    Approximately 30 healthy participants will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
    Interventions:
    • Drug: Xenon contrast agent
    • Device: Magnetic Resonance Imaging
  • Experimental: Diagnosis unspecified
    Approximately 60 participants with diagnosis unspecified will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
    Interventions:
    • Drug: Xenon contrast agent
    • Device: Magnetic Resonance Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2017)
126
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2011)
120
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Moyamoya Patient Inclusion Criteria:

  • Men and non-pregnant women, at least 21 years of age.
  • Outpatients seen at the Stanford Neurosurgery and Neurology Departments.
  • Ability to comply with all studies.
  • Inclusion of Moyamoya patients with Sulfa allergies.
  • Patients diagnosed with or suspected to have Moyamoya disease.

Stroke Patient Inclusion Criteria:

  • Men and non-pregnant women, at least 21 years of age.
  • Patients admitted to the inpatient Stanford Stroke Service for stroke-like symptoms, less than 24 hours from last time seen normal.
  • Ability to comply with all studies.

Clinical Patient Acetazolamide MRI Inclusion Criteria:

  • Men and non-pregnant women, at least 21 years of age.
  • Patients admitted to the inpatient Stanford Stroke Service or Neurosurgical -Service for symptoms compatible with cerebrovascular disease.
  • Ability to comply with all studies.

Normal Subject Inclusion Criteria:

  • Ability to comply with the MRI study.

Exclusion Criteria:

  • Level of consciousness score of 2 or greater as defined by the NIH stroke scale.
  • Symptoms likely related to psychoactive drugs or patients with symptoms related to an active inflammatory disease such as AIDS, meningitis, or cerebritis.
  • Psychiatric or substance abuse disorder or dementia that interferes with evaluation or interpretation of the neurologic and mental assessment of these patients.
  • Informed consent cannot be obtained either from the patient or legal representative.
  • Severe coexisting or terminal systemic disease that limits life expectancy or that may interfere with the conduct of the study.
  • Symptoms related to an alternative diagnosis such as seizures or migraine.
  • Patients receiving any thrombolytic agent or receiving acute stroke investigational drug therapies during the 30-day study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01419275
Other Study ID Numbers  ICMJE SU-06152011-7929
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Greg Zaharchuk, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Greg Zaharchuk Stanford University
PRS Account Stanford University
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP