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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01419275

First Posted: August 18, 2011

Last Update Posted: August 30, 2017

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.

Information provided by (Responsible Party):

Greg Zaharchuk, Stanford University

Purpose

Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients

Condition	Intervention
Cerebrovascular Accident Moyamoya Disease	Drug: Xenon contrast agent Device: Magnetic Resonance Imaging


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: moyamoya disease

Genetic and Rare Diseases Information Center resources: Moyamoya Disease

U.S. FDA Resources

Further study details as provided by Greg Zaharchuk, Stanford University:

Primary Outcome Measures:

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.


Enrollment:	126
Study Start Date:	April 2009
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Senior
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

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


United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators


Principal Investigator:	Greg Zaharchuk	Stanford University

More Information


Responsible Party:	Greg Zaharchuk, Principle Investigator, 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
Last Verified:	July 2017

Additional relevant MeSH terms:


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

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