Protective Effects of Edaravone Dexborneol in Patients With Acute Ischemic Stroke by Improving Ischemic Penumbra and Collateral Circulation of Hypoperfusion Areas
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- image changes in different groups
研究概览
简要总结
The patients of acute ischemic stroke were divided into two groups, edaravone dexborneol treatment group and edaravone treatment group. The purpose of this study was to observe the changes of imaging and the improvement of NIHSS and mRS in different groups.
详细描述
A total of 80 patients with acute ischemic stroke of middle cerebral artery were randomly divided into two groups, edaravone dexborneol treatment group and edaravone treatment group. The mismatch area between the low perfusion area of MRI 3D-ASL and the infarct area of DWI was defined as the ischemic penumbra, and the CBF perfusion pseudo color images with PLD of 1.5s and 2.5s were recorded. The above two CBF perfusion images were subtracted, and the residual area was quantitatively analyzed to reflect the establishment of collateral circulation. We aimed to observe whether there were differences in the improvement of ischemic penumbra and the establishment of collateral circulation between two groups after treatment. Besides, the improvment of NIHSS and mRS was also observed in different periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 50 to 80 years old;
- •Patients diagnosed as acute ischemic stroke according to Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018 and who met the requirements of middle cerebral artery blood supply area infarction (except deep perforator disease) without treatment;
- •Brain MR showed that the low perfusion area of ASL was at least 20% larger than that of DWI core infarct area, and the contralateral mirror brain tissue was basically normal;
- •NIHSS score was between 4 to 24;
- •Patient or their legal representatives were willing to sign the informed consent form.
排除标准
- •Serious mental abnormality, complicated with heart, lung, liver, renal insufficiency or malignant tumor and other serious diseases;
- •Combined with cerebral vascular malformation or cerebral hemorrhage;
- •Pregnant or lactating women;
- •Allergic to edaravone or dexborneol;
- •There are interactions between the drugs being taken by patients and the study drug or affect the clinical trial parameters.
研究组 & 干预措施
edaravone dexborneol group
干预措施: edaravone dexborneol or edaravone (Drug)
edaravone group
干预措施: edaravone dexborneol or edaravone (Drug)
结局指标
主要结局
image changes in different groups
时间窗: 7 days
次要结局
- mRS changes in different groups(7days，14 days, 90 days)
- NIHSS changes in different groups(7days，14 days, 90 days)
研究者
Lili Cao
Professor
Qianfoshan Hospital