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

Not Applicable

Completed

• Conditions: Cerebrovascular Accident; Moyamoya Disease
• Interventions: Drug: Xenon contrast agent; Device: Magnetic Resonance Imaging

• Registration Number: NCT01419275
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-18
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Results First Submitted: 2016-12-21
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-29
• Last Update Submitted: 2017-07-29
• Results First Posted: 2017-08-30
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acute stroke	Xenon contrast agent	Approximately 60 acute stroke patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
Healthy participants	Xenon contrast agent	Approximately 30 healthy participants will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
Moyamoya	Xenon contrast agent	Approximately 60 Moyamoya patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
Moyamoya	Magnetic Resonance Imaging	Approximately 60 Moyamoya patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
Acute stroke	Magnetic Resonance Imaging	Approximately 60 acute stroke patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
Diagnosis unspecified	Xenon contrast agent	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.
Healthy participants	Magnetic Resonance Imaging	Approximately 30 healthy participants will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
Diagnosis unspecified	Magnetic Resonance Imaging	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity)	performed one time within 1 week prior to surgery	Sensitivity and specificity for MRI-based ASL measure of presence of collaterals was measured using digital subtraction angiography as a gold standard. Measurements were for 20 regions per patient were scored as either positive or negative for collateral flow. A positive value (results) means the region is supplied by collateral flow. Negative means the region is supplied by antegrade (normal) flow. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States