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临床试验/NCT07292974
NCT07292974尚未招募不适用

DYNAMIC CHANGES OF ENDOTHELIAL GLYCOCALYX AND INFLAMMATORY RESPONSE IN PATIENTS WITH ACUTE STROKE TREATED WITH MECHANICAL THROMBECTOMY

Clinical Hospital Centre Zagreb0 个研究点目标入组 150 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
主要终点
Cytokine concentrations (IL 6, IL 10)

研究概览

简要总结

Ischemic stroke (IS) is one of the leading causes of mortality and disability. Treatment of IS is based on reperfusion methods, thrombolysis and mechanical thrombectomy (MT). However, there are significant limitations in their implementation and success. Also, there is a mismatch between successful recanalization of the blood vessel, recovery of the neurological status as well as treatment outcome. Precisely for these reasons, there is a need for a better understanding of pathophysiology events in the acute IS and for the development of new therapeutic procedures that would include neuroprotection, modification of the inflammatory response and preservation of the integrity of the blood-brain barrier. Acute IS occurs as a result of a blood vessel blockage, which leads to ischemic damage to the brain parenchyma. It causes an early inflammatory response that is extremely complex, involving a large number of inflammatory cytokines whose dynamics and role in the pathophysiology of IS are insufficiently investigated. It is known that inflammatory processes damage the endothelial glycocalyx (EG), a thin luminal layer of the endothelium that has numerous functions such as maintaining the integrity of blood vessels and regulating tone, and itself participates in the inflammatory response. In the brain, EG is a key regulator of the integrity of the blood-brain barrier, and its damage makes the barrier more permeable, which can lead to edema and the passage of potentially harmful substances. Clinical studies have shown that there is a possible relationship between the prognosis of patients with IS and the concentration of EG breakdown products in the peripheral blood. However, the relationship between changes in EG and the inflammatory process in the context of IS, and especially in relation to available treatment methods, remains unclear. The aim of the proposed study is to determine and analyze the dynamics of concentrations of EG degradation products and inflammatory cytokines in patients with acute IS during and after MT. This study would include all adult patients with acute IS who will undergo MT, and the concentrations of EG degradation products and inflammatory cytokines would be determined by the enzyme immunoassay method from peripheral blood and blood samples from the cerebral circulation after reperfusion. The obtained results will be correlated with the collected data on the neurological condition of the patient before and after the intervention, the type and course of the intervention performed, the course and duration of hospital treatment, the occurrence of complications and the outcome of treatment.

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

入选标准

  • all patients older than 18 years with a diagnosis of acute IS confirmed by brain CT or MRI, and to whom MT will be performed, regardless of whether they are previously received thrombolysis.

排除标准

  • patients under the age of 18, patients with diagnosed with hemorrhagic stroke, patients with acute infection, autoimmune illness, malignant disease, trauma, pregnant women or patients who will refuse to participate in research.

结局指标

主要结局

Cytokine concentrations (IL 6, IL 10)

时间窗: 24 hours

Measure and analyze cytokine concentrations (IL 6, IL 10) in peripheral blood during the intervention and 24 hours after revascularization/attempted revascularization.

Concentrations of EG degradation products (syndecan 1, heparan sulfate) and the neovascularization factor VEGF in peripheral blood during the intervention and 24 hours after revascularization/attempted revascularization.

时间窗: 24 hours

To measure and analyze the concentrations of EG degradation products (syndecan 1, heparan sulfate) and the neovascularization factor VEGF in peripheral blood during the intervention and 24 hours after revascularization/attempted revascularization. Additionally, the concentrations of EG degradation products in a blood sample from the occlusion site after revascularization will be measured and analyzed.

次要结局

未报告次要终点

研究者

发起方
Clinical Hospital Centre Zagreb
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marijana Matas

MD

Clinical Hospital Centre Zagreb

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