MicroRNA Diagnostics in Subarachnoid Hemorrhage 2
研究概览
详细说明
In this study of patients suffering an aneurysmal subarachnoid hemorrhage (SAH) we would like to validate former results from CSF studies through microRNA profiling investigate the pathophysiological mechanisms that lead to systemic complications such as cardiac dysfunction, acute lung injury (ALI) and systemic inflammatory response syndrome(SIRS).
We will accomplish this through analyzing the profile of microRNA expression in blood and cerebrospinal fluid from SAH patients.
Validation:
As in our earlier study we wish to compare the expression of 20 specific microRNA between 12 patients developing DCI (group 1) and 12 patients without DCI (group 2) in cerebrospinal fluid drawn on day 5 after ictus. In addition, some of the patients will have established invasive neuromonitoring including microdialysis in which we will study changes of certain microRNAs.
DCI as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395:
"The occurrence of focal neurological impairment (such as hemiparesis, aphasia, apraxia, hemianopia, or neglect), or a decrease of at least 2 points on the Glasgow Coma Scale (either on the total score or on one of its individual components [eye, motor on either side, verbal]). This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes by means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies."
Systemic complications:
Furthermore, we wish to compare the expression of 754 specific microRNA in blood drawn on day 3 after ictus between patients with ALI (as described Kahn et al, Crit Care Med. 2006; 34: 196-202) and patients without ALI. Of at least 36 patients expected to be included 12 should statistically develop ALI according to the referred definition.
Additionally, we wish to compare the expression of 754 specific microRNA between 12 patients developing DCI (group 1) and 12 patients without DCI (group 2) in blood drawn on day 3 after ictus.
Moreover, we wish to compare the expression of 754 specific microRNA in blood between 36 patients (group 1-3) to that of healthy controls. The specific microRNAs of interest in which the expression in blood between patients with systemic complication are analyzed daily to investigate the dynamic changes in expression and compared to the clinical course.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Copenhagen、丹麦、2100
- Rigshospitalet
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Group 1-2: Patients admitted to Neurointensive Department in Rigshospitalet with SAH treated with external ventricular drain.
Group 3: Patients admitted to Neurointensive Department in Rigshospitalet with SAH treated without external ventricular drain.
Group 4: Healthy blood donors
描述
Inclusion Criteria Group 1-3:
- Uncertainty < 24 times on time of ictus
Inclusion Criteria Group 1-2:
- Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated with external ventricular drain.
Inclusion Criteria Group 3:
- Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated without external ventricular drain.
Exclusion Criteria Group 1-3:
- Transfer to other hospital within 5 days of admission
学习计划
研究是如何设计的？
设计细节
- 观测模型：病例对照
- 时间观点：预期
队列和干预
团体/队列 |
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SAH with DCI
After 21 days from ictus the patients with subarachnoid hemorrhage are stratified to group 1 or 2 depending on their development of delayed cerebral ischemia.
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SAH without DCI
After 21 days from ictus the patients with subarachnoid hemorrhage are stratified to group 1 or 2 depending on their development of delayed cerebral ischemia.
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SAH good grade
SAH without external ventricular drainage
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Healthy controls
Blood sample in healthy donors registered in the National Donor Registry.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Delayed Cerebral Ischemia
大体时间：21 days
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Delayed Cerebral Ischemia as defined by Vergouwen et al[1]. In our earlier study we found the clinical condition DCI somehow subjective which is why we added the following two primary outcome measures. Comparing microRNA profiles between groups with or without. |
21 days
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Delayed Cerebral Ischemia and Cerebral infarction
大体时间：21 days
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as defined by Vergouwen et al [1]. Comparing microRNA profiles between groups with or without. |
21 days
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Delayed Cerebral infarction
大体时间：21 days
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as defined by Vergouwen et al [1]. Comparing microRNA profiles between groups with or without. |
21 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Acute Lung Injury
大体时间：21 days
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as defined by Kahn et al[2]. Comparing microRNA profiles between groups with or without |
21 days
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Cardiac Dysfunction
大体时间：21 days
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Evaluated by transthoracic echocardiography Comparing microRNA profiles between groups with or without |
21 days
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Systemic Inflammatory Response Syndrome
大体时间：21 days
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Evaluated through daily vital signs and biochemistry Comparing microRNA profiles between groups with or without |
21 days
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Early Brain Injury
大体时间：Clinical evaluation 24-72 hours after ictus. (Wake-up call if sedated)
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Early Brain injury = GCS 3-12 and/or paresis (degree 4) of at least one extremity or aphasia No Early Brain injury = GCS 13-15 and no or only small and mild focal deficit Comparing microRNA profiles between groups with or without |
Clinical evaluation 24-72 hours after ictus. (Wake-up call if sedated)
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合作者和调查者
调查人员
- 研究主任：Kirsten Møller, Prof、Neurointensive Care Unit, The Neuroscience Center, Rigshospitalet
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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