Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity)
研究概览
简要总结
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Moyamoya
Approximately 60 Moyamoya patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
干预措施: Xenon contrast agent (Drug)
Moyamoya
Approximately 60 Moyamoya patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
干预措施: Magnetic Resonance Imaging (Device)
Acute stroke
Approximately 60 acute stroke patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
干预措施: Xenon contrast agent (Drug)
Acute stroke
Approximately 60 acute stroke patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
干预措施: Magnetic Resonance Imaging (Device)
Healthy participants
Approximately 30 healthy participants will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
干预措施: Xenon contrast agent (Drug)
Healthy participants
Approximately 30 healthy participants will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
干预措施: Magnetic Resonance Imaging (Device)
Diagnosis unspecified
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.
干预措施: Xenon contrast agent (Drug)
Diagnosis unspecified
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.
干预措施: Magnetic Resonance Imaging (Device)
结局指标
主要结局
Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity)
时间窗: 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.
次要结局
未报告次要终点
研究者
Greg Zaharchuk
Principle Investigator
Stanford University