Diagnostic evaluation of Plasma GFAP for the rapid differentiation between Ischemic Stroke and Intracerebral Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of GFAP for differentiating patients with ICH from patients with ischemic stroke (including TIA) and stroke mimics.
研究概览
简要总结
Stroke is the second most common cause of death globally.
To date, brain imaging is the gold standard for distinguishing patients with ischemic stroke and intracerebral hemorrhage, which requires hospital admittance of patients with symptoms suspicious for acute stroke and causes a tremendous time-to-treatment delay.
A rapid and reliable diagnostic test to distinguish ischemic from hemorrhagic stroke is essential to optimize management and triage for thrombolytic therapy.
Several studies conducted by Dr. Förch, a Neurologist in Germany, have shown that the brain-specific biomarker GFAP is released rapidly in acute ICH, whereas a more delayed release can be observed in patients with ischemic stroke.
Now it is important to replicate these findings in other populations as well. Based on the higher incidence rates in Asia and potential racial differences in GFAP release between Asian and Caucasian populations, the diagnostic accuracy of the GFAP testing need to be re-evaluated in a study performed in Asian countries.
This shall be done by testing the plasma concentration of GFAP of 200 patients admitted to CMC, Ludhiana with symptoms suspicious of acute stoke (targeting 80 patients with ICH and 120 patients with ischemic stroke or stroke mimics).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Presence of neurological symptoms at hospital admission suspicious for acute stroke
- •Time interval from symptom onset to study inclusion < 12 h.
排除标准
- •Ischemic stroke, intracerebral hemorrhage or transient ischemic attack within the last three months
- •Patients participating in other stroke trials/research
- •Known history of brain tumor at any time in patient history
- •Evidence for traumatic brain injury with the last 3 months
- •Participant in another stroke study
- •Informed consent not given.
结局指标
主要结局
1. Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of GFAP for differentiating patients with ICH from patients with ischemic stroke (including TIA) and stroke mimics.
时间窗: 1 month after the end of recruitment phase
2. Gold standard is the diagnosis of ICH, ischemic stroke (including TIA), or stroke mimic as determined at the end of hospital stay based on all available information.
时间窗: 1 month after the end of recruitment phase
次要结局
- 1. Analysis stratified for patients with a moderate to severe neurological deficit (NIHSS 9).(2. Analysis stratified for patients with different time windows (2 h, 2 to 6 h, 6 to 12 h) from symptom onset to blood withdrawal.)