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Trial record 1 of 1 for:    NCT01419275
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Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients

This study has been completed.
Information provided by (Responsible Party):
Greg Zaharchuk, Stanford University Identifier:
First received: August 16, 2011
Last updated: April 12, 2016
Last verified: April 2016
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients

Condition Intervention
Cerebrovascular Accident
Moyamoya Disease
Drug: Xenon as contrast agent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Arterial spin labeling in magnetic resonance imaging to assess collateral blood flow [ Time Frame: performed one time prior to surgery ]

Enrollment: 120
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, acute stroke, other

Approximately 210 participants will be enrolled, including the following groups:

60 Moyamoya patients, 60 acute stroke patients, 30 healthy participants and 60 patients with diagnosis unspecified

Drug: Xenon as contrast agent
Other Name: XeMED contrast agent

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.

Ages Eligible for Study:   Child, Adult, Senior
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.
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Please refer to this study by its identifier: NCT01419275

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Greg Zaharchuk Stanford University
  More Information

Responsible Party: Greg Zaharchuk, Principle Investigator, Stanford University Identifier: NCT01419275     History of Changes
Other Study ID Numbers: SU-06152011-7929
Study First Received: August 16, 2011
Last Updated: April 12, 2016

Additional relevant MeSH terms:
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 processed this record on May 25, 2017