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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01419275
First received: August 16, 2011
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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 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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01419275     History of Changes
Other Study ID Numbers: SU-06152011-7929
Study First Received: August 16, 2011
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cerebrovascular Disorders
Moyamoya Disease
Cerebral Infarction
Stroke
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
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 21, 2014