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临床试验/NCT01787877
NCT01787877Unknown不适用

Inflammatory Biomarkers as Additional Tool to Neuroimaging in the Diagnosis and Management of Patients With Ischemic Stroke

Ziv Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Relationship between inflammatory biomarkers and CVA patients

研究概览

简要总结

Stroke represents the third commonest cause of death after heart disease and all types of cancer combined, and is the leading cause of long-term permanent disability among adults. Recombinant tissue plasminogen activator (tPA) is currently the only safe medical treatment for acute ischemic stroke but only a small fraction of patients are eligible for a thrombolysis treatment. Current guidelines on thrombolysis post stroke with tPA exclude its uses beyond 3 hours after stroke onset and when time of onset is unknown thus excluding many patients from potentially beneficial treatment.

For an appropriate triage and management of patients, it is essential to improve imaging techniques beyond a simple CT scan. Perfusion computed tomography (PCT), currently considered as an investigational technique, permits a quantitative determination of the cerebral perfusion within the brain. It helps distinguish salvageable ischemic penumbra from irreversibly infarcted core in acute stroke patients. This technique has therefore the potential to select patients who are most likely to benefit from thrombolysis with tPA, can be used to predict the benefit after thrombolysis and determine the suitability for other therapeutic interventions. In patients with a primary diagnosis of TIA, PCT would help to identify possible persistent cerebral ischemia but also provide important information for rapid instigation of prophylactic strategies.

The diagnosis and management of patients with ischemic stroke and TIA is challenging and is primarily based on clinical assessment in conjunction with neuroimaging. Development of specific molecular biomarkers as additional tools to support a clinical diagnosis, exclude common stroke mimics such as migraine or epileptic seizures, identify patients at risk of disease, and help guide patient treatment by predicting complications following t-PA treatment would be of great value.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
  • Diagnosis of acute clinical stroke
  • Ages 18 and above inclusive
  • Both genders eligible for the study

排除标准

  • Intracerebral hemorrhage according to Computed Tomography (CT)
  • Clinical signs of infection on admission
  • Patients with chronic inflammatory disease
  • Hematologic disorders (anemia)
  • Malignant tumor
  • Renal or hepatic failure
  • Treatment with anti-inflammatory or corticosteroids drugs within a month before stroke

结局指标

主要结局

Relationship between inflammatory biomarkers and CVA patients

时间窗: Follow-up 1 year

To assess the levels over the time of selected inflammatory biomarkers, to determine the relationship between them after acute ischemic stroke and to evaluate their correlation with patients characteristics

次要结局

  • Identify patients at risk of recurrent stroke by identifying molecular biomarkers(Follow-up for 1 year)

研究者

发起方
Ziv Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Saad Abu Saleh

Medical Sub Investigator

Ziv Hospital

研究点 (1)

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