Back to resultsQuantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
Primary Purpose
Cerebrovascular Accident, Moyamoya Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Xenon contrast agent
Magnetic Resonance Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Cerebrovascular Accident
Eligibility 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.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Moyamoya
Acute stroke
Healthy participants
Diagnosis unspecified
Arm Description
Approximately 60 Moyamoya patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
Approximately 60 acute stroke patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
Approximately 30 healthy participants will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
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.
Outcomes
Primary Outcome Measures
Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01419275
Brief Title
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
Official Title
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Moyamoya Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moyamoya
Arm Type
Experimental
Arm Description
Approximately 60 Moyamoya patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
Arm Title
Acute stroke
Arm Type
Experimental
Arm Description
Approximately 60 acute stroke patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
Arm Title
Healthy participants
Arm Type
Experimental
Arm Description
Approximately 30 healthy participants will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
Arm Title
Diagnosis unspecified
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Xenon contrast agent
Other Intervention Name(s)
XeMED contrast agent
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
Arterial spin label sequence for the purpose of measuring collateral flow
Primary Outcome Measure Information:
Title
Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity)
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Zaharchuk
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
We'll reach out to this number within 24 hrs