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

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.
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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.
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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.
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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 |
- 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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Greg Zaharchuk | Stanford University |
Responsible Party: | Greg Zaharchuk, Principle Investigator, Stanford University |
ClinicalTrials.gov Identifier: | NCT01419275 |
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 |
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 |