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临床试验/NCT02824406
NCT02824406Unknown不适用

Cerebrovascular Reserve Measurements in Sickle Cell Disease: an MRI Study

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Cerebrovascular Reserve (CVR) from arterial spin labelling-MRI in patients compared to controls

研究概览

简要总结

The primary aim of this study is to evaluate MRI-based cerebrovascular reserve (CVR) measurements in adult patients with Sickle Cell Disease (SCD).

The primary objective is to assess whether there is a correlation between CVR and silent cerebral infarcts (SCIs).

详细描述

CVR is hypothesized to be impaired in SCD patients and could account for the white matter hyperintensities seen on MRI in these patients. Cerebral blood flow (CBF) alone is not sufficient to provide insight into the hemodynamic status of the brain. CVR allows us to gain insight into the capacity of the cerebrovasculature to respond to increased CBF. Vasculopathy is common in SCD and the caliber of the vessels can be assessed with 4D Flow MRI in response to actue and chronic changes in the velocity and wall shear stress on the intracranial arteries in the Circle of Willis.

This study will be performed as a single center, patient-control, cross-sectional, observational study in patients with steady-state SCD and controls. The investigators expect that patients with impaired CVR will have a greater number and/or volume of SCIs.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Patients

CVR assessment consists of CBF measurement with arterial spin labelling (ASL)-MRI before and after intravenous administration of 16mg/kg acetazolamide (Diamox)

干预措施: Acetazolamide (Drug)

Controls

CVR assessment consists of CBF measurement with arterial spin labelling (ASL)-MRI before and after intravenous administration of 16mg/kg acetazolamide (Diamox)

干预措施: Acetazolamide (Drug)

结局指标

主要结局

Cerebrovascular Reserve (CVR) from arterial spin labelling-MRI in patients compared to controls

时间窗: 20 minutes

Cerebral blood flow (CBF mL/100g/min) measurement before, during, and after, an intravenous administration of 16mg/kg acetazolamide. The percentage change in CBF will be used as a measure for CVR (%).

次要结局

  • Cerebral Metabolic Rate of Oxygen in patients and controls(2 minutes)
  • Blood markers relating to anemia will be related to MRI findings(Through study completion, an average of 1 year)
  • Silent Cerebral Infarct (SCI) on T2-weighted FLAIR MRI(10 minutes)
  • Velocity in the circle of willis assessed with 4D Flow MRI(10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

B.J. Biemond

Dr.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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