Contrast Enhanced Ultrasound Imaging for Cerebral Perfusion Measurement in Cerebral Vasospasm After Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Detection of cerebral hypoperfusion leading to either infarcts, neurological deficits, or initiation of rescue therapy
研究概览
简要总结
The objective of the study is to assess brain tissue perfusion by ultrasound perfusion imaging. Specifically
- to diagnose brain tissue hypoperfusion due to CVS with contrast enhanced UPI and to assess specificity and sensitivity, and predictive values for detection of brain tissue hypoperfusion leading to infarction
- to test whether treatment-effects by induced hypertension, balloon-dilatation, or intra-arterial nimodipine infusion can be detected and quantified by UPI
详细描述
The aim of the study is to assess brain tissue perfusion by ultrasound perfusion imaging (UPI).
The specific aim is to diagnose brain tissue hypoperfusion leading to infarction due to CVS with ultrasound perfusion imaging (UPI) and to correlate it with the gold standard of diagnosis of brain infarcts, i.e. with MRI and CT. According to contrast enhanced UPI brain tissue will be classified as (1) normal, i.e. not leading to tissue infarction, (2) as hypoperfused, i.e. functionally impaired and prone to DIND and to infarction, or (3) non-perfused. Thus, temporary hypoperfusion that may be resolved by therapy or spontaneously, not leading to tissue infarction shall be assessed. This strategy will lead to guiding therapy by UPI.
Questionnaire:
- to assess cerebral perfusion in patients with SAH by contrast enhanced UPI
- to assess specificity and sensitivity, as well as positive and negative predictive values of contrast enhanced UPI for detection of brain tissue misery perfusion leading to infarction
- to evaluate feasibility and practicability of repeated bed-side assessments of UPI
- to test whether treatment-effects like induced hypertension, balloon-dilation, or intra-arterial nimodipine infusion can be detected and quantified by contrast enhanced UPI
- to analyze whether TCD or contrast enhanced UPI is superior for screening of CVS and detection of cerebral infarcts (vessel vs. tissue assessment)
- to correlate contrast enhanced UPI with perfusion measurements by CT-perfusion imaging
Ultrasound perfusion imaging (UPI) is able to detect cerebral hypoperfusion that can result in cerebral infarction in a clinical setting. As reference the incidence of cerebral infarcts is assessed by CT- and MR-imaging and cerebral perfusion is analyzed by CT-perfusion (CTP) imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven SAH (CT or lumbar puncture)
- •Proven aneurysm (digital subtraction angiography or CT-angiography)
- •Informed consent of patient or relative
排除标准
- •Pregnancy and breast feeding
- •Acute coronary syndromes, severe ischemic heart disease (requiring revascularisation), severe aortic and mitral valve disease, severe congestive heart failure (NYHA >III/IV)
- •Severe pulmonary or renal dysfunction
- •Known allergy or adverse reaction to contrast material
结局指标
主要结局
Detection of cerebral hypoperfusion leading to either infarcts, neurological deficits, or initiation of rescue therapy
时间窗: 14 days after ictus
(1) normal, i.e. with a perfusion delay \< 2 sec, (2) hypoperfusion, i.e. with a perfusion delay ≥ 2sec and \< 6 sec, and (3) no perfusion, i.e. with a perfusion delay ≥ 6 sec as compared with the average of the 2 thalamic territories of the unaffected side
次要结局
- Correlation between UPI parameters and cerebral perfusion as assessed by MRI-perfusion(Within 14 days after ictus)
- Correlation between UPI parameters with vessel diameters of the MCA as assessed by DSA(Within 14 days after ictus)
- Correlation between UPI parameters and cerebral perfusion as assessed by CT-perfusion(Within 14 days after ictus)
- Correlation between UPI parameters and flow velocities in the middle cerebral artery as measured by TCD(Within 14 days after ictus)