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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 Description
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Brief Summary:
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Moyamoya Disease Drug: Xenon contrast agent Device: Magnetic Resonance Imaging Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
Study Start Date : April 2009
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Xenon

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Xenon contrast agent
Other Name: XeMED contrast agent

Device: Magnetic Resonance Imaging
Arterial spin label sequence for the purpose of measuring collateral flow
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.
 Drug: Xenon contrast agent
Other Name: XeMED contrast agent

Device: Magnetic Resonance Imaging
Arterial spin label sequence for the purpose of measuring collateral flow
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.
 Drug: Xenon contrast agent
Other Name: XeMED contrast agent

Device: Magnetic Resonance Imaging
Arterial spin label sequence for the purpose of measuring collateral flow
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.
 Drug: Xenon contrast agent
Other Name: XeMED contrast agent

Device: Magnetic Resonance Imaging
Arterial spin label sequence for the purpose of measuring collateral flow


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419275


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Greg Zaharchuk Stanford University
More Information
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Responsible Party: Greg Zaharchuk, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01419275     History of Changes
Other Study ID Numbers: SU-06152011-7929
First Posted: August 18, 2011    Key Record Dates
Results First Posted: August 30, 2017
Last Update Posted: August 30, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Moyamoya Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
 Cerebral Arterial Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs