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

Stanford University

Status: Completed

Conditions: Cerebrovascular Accident; Moyamoya Disease

Treatments: Drug: Xenon contrast agent; Device: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01419275

SU-06152011-7929

Details and patient eligibility

About

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

Full 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.

Enrollment: 126 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 4 patient groups

Moyamoya

Experimental group

Description:

Approximately 60 Moyamoya patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.

Treatment:

Device: Magnetic Resonance Imaging

Drug: Xenon contrast agent

Acute stroke

Experimental group

Description:

Approximately 60 acute stroke patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.

Treatment:

Device: Magnetic Resonance Imaging

Drug: Xenon contrast agent

Healthy participants

Experimental group

Description:

Approximately 30 healthy participants will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.

Treatment:

Device: Magnetic Resonance Imaging

Drug: Xenon contrast agent

Diagnosis unspecified

Experimental group

Description:

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.

Treatment:

Device: Magnetic Resonance Imaging

Drug: Xenon contrast agent