Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients - Full Text View

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:

Genetics Home Reference related topics: cerebral autosomal recessive arteriopathy with subcortical infarcts and leukoencephalopathy moyamoya disease

Genetic and Rare Diseases Information Center resources: Moyamoya Disease

U.S. FDA Resources

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


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Greg Zaharchuk, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier:	NCT01419275 History of Changes
Other Study ID Numbers:	SU-06152011-7929
Study First Received:	August 16, 2011
Last Updated:	April 12, 2016
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2016