Clinical Implications of a Panel of Immunological Biomarkers in Patients With Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Predictive immune score for favorable outcome
研究概览
简要总结
Stroke is accompanied by local inflammatory response and systemic immunosuppression. Immunosuppression markers are associated with the occurrence of medical complications (infections), whereas inflammatory markers are associated with worse functional prognosis.
This prospective study tries to validate in acute stroke patients the prognostic usefulness of a panel of immune biomarkers that have previously been associated with various clinical outcomes.
The identification of beneficial and harmful immune responses in cerebral ischemia will allow the prediction of the clinical course of the patients and will be helpful in designing immunomodulatory therapeutic strategies for acute stroke.
详细描述
Stroke is accompanied by local inflammatory response and systemic immunosuppression. Immunosuppression markers are associated with the occurrence of medical complications (infections), whereas inflammatory markers are associated with worse functional prognosis.
This prospective study tries to validate in acute stroke patients the prognostic usefulness of a panel of immune biomarkers that have previously been associated with various clinical outcomes. The immune biomarkers will be assessed at admission, at day 1 after admission and at day 90. The assessed immune biomarker panel includes:
- Serum cortisol levels.
- Serum interleukin (IL)-10 levels.
- Proportion of circulating B lymphocytes (CD3-CD19+ cells).
- Monocyte surface expression of TLR4, HLA-DR, CD86, and VLA-4.
- Ex - vivo production of tumor necrosis factor (TNF)-α in monocytes after stimulation with LPS.
- Proportion of each of the circulating monocyte subpopulations (CD14highCD16-, CD14highCD16+, and CD14dimCD16+).
The identification of beneficial and harmful immune responses in cerebral ischemia will allow the prediction of the clinical course of the patients and will be helpful in designing immunomodulatory therapeutic strategies for acute stroke.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ischemic stroke*
- •stroke onset within 6h*
- •treated with systemic or intraarterial thrombolysis*
- •minimum severity in the NIHSS of 3*
- •consent by the patient or the legal representative
- •These items do not apply for healthy subjects.
排除标准
- •intracranial hemorrhage
- •signs of infection at admission
- •use of antibiotics, immunosuppressors or corticosteroids in the previous 3 months
- •significant disability (mRS>2) before index stroke
结局指标
主要结局
Predictive immune score for favorable outcome
时间窗: 90 +-15 days after onset of symptoms
To establish a predictive immune score for functional outcome. Favorable outcome is defined as a modified Rankin Scale (mRS) score of \<3 at day 90+-15 after stroke
Predictive immune score for stroke associated infection
时间窗: 7 days after onset of symptoms
To establish a predictive score for stroke associated infection (SAI) based on immune biomarkers. Stroke associated infection is defined as: body temperature \> 37.7ºC and symptoms of infection (cough, dyspnea, pleuritic pain, dysuria), or leukocytosis \>11000, leukopenia \<4000, pulmonary infiltrates in chest X-ray or positive cultures for a pathogen.
次要结局
- Localization and stroke volume analysis(SAI within 7 days and neurological outcome after 3 months after onset of symptoms)
- Thrombolysis, immune biomarkers and SAI(SAI within 7 days after onset of symptoms)
- Infection and functional outcome after ischemic stroke(SAI within 7 days after onset of symptoms and neurological outcome after 3 months)
- Predictive immune score for ischemic progression(7 days after onset of symptoms)
- Predictive immune score for functional outcome over the entire mRS(90 +-15 days after onset of symptoms)
- Insular cortex involvement and infarct volume(SAI within 7 days and and on the neurological outcome after 3 months)
研究者
Angel Chamorro, M.D., Ph.D.
Ángel Chamorro
Hospital Clinic of Barcelona