Clinical trial NCT01419275: Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
Official title: Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Moyamoya Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-08-18
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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 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.

Primary outcomes:
measure: Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity)
timeFrame: performed one time within 1 week prior to surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Greg Zaharchuk
role: PRINCIPAL_INVESTIGATOR
References: