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

• 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: Stanford University
• Information provided by (Responsible Party): Greg Zaharchuk, Stanford University

Study Description

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

• 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

Arms and Interventions

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

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

• 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

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
• Other Study ID Numbers: SU-06152011-7929
• First Posted: August 18, 2011
• 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