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临床试验/NCT05228080
NCT05228080Unknown不适用

Predictive Study of Serum Endocan for Hemorrhagic Transformation After Reperfusion Therapies in Acute Ischemic Stroke

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Incidence of Hemorrhagic Transformation after reperfusion therapy

研究概览

简要总结

Stroke is the second largest cause of death globally after ischemic heart disease.Of the total number of prevalent strokes, 84.4% are ischemic. Reperfusion therapy is the most important treatment for acute ischemic stroke (AIS) ,including intravenous thrombolysis and/or endovascular treatment.However,the most serious and common complication with reperfusion therapy is hemorrhage transformation(HT),which significantly increases disability and mortality. The fundamental mechanism leading to post-stroke HT is the disruption of the blood brain barrier(BBB) and increase of permeability.Endocan plays a critical role in vascular inflammatory responses by enhances the production of pro-inflammatory cytokines by endothelial cells,the expression of adhesion molecules such as inter-cellular adhesion molecule-1(ICAM-1) and vascular cell adhesion molecule-1(VCAM-1),and the adhesion of leukocytes to endothelial cells. Endocan significantly decreases levels of zonula occludens(ZO-1) and occludin which are tight junction proteins that play major roles in the maintenance of vascular barriers. Endocan could induce vascular endothelial growth factor-A(VEGF-A) and facilitate the binding of VEGF-A to its receptor(VEGFR-2) to enhanced endothelial permeability.Therefore,endocan is a reliable biomarker of endothelial dysfunction, which may be associated with disruption of the BBB. In this context, the investigators hypothesized that elevated pretreatment serum endocan levels might be independently associated with HT after reperfusion therapy in the acute phase of ischemic stroke. Serum endocan,ICAM-1,VCAM-1 and matrix metalloproteinase-9(MMP-9) levels will be determined by enzyme-linked immunosorbent assay(ELISA) in blood samples obtained at baseline (pretreatment) and at 12,24 hours after reperfusion therapy in patients with acute stroke and in healthy subjects.In the present study,the investigators attempt to investigate whether high levels of endocan are associated with HT in patients who received reperfusion therapy.In addition,the investigators explore the association between serum endocan and early neurological deterioration and unfavourable short-term prognosis.

研究设计

研究类型
Observational
观察模型
Other
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

  • Clinical diagnosis of acute ischemic stroke and presentation at the hospital within 24h from symptom onset
  • Eligibility for intravenous thrombolysis and/or endovascular treatment
  • Age ≥18 years

排除标准

  • Administration of intravenous thrombolysis at another hospital in patients who are candidates for endovascular treatment
  • Contraindications to intravenous thrombolysis
  • Contraindications to iodinated contrast agent
  • A history of ischemic stroke in three months
  • Clinical diagnosis of autoimmune,inflammatory, hematological, or infectious diseases
  • Clinical diagnosis of cancer
  • Clinical diagnosis of severe cardiac,pulmonary,renal or liver failure
  • Clinical diagnosis of dementia or psychosis
  • Pregnant and lactating women

结局指标

主要结局

Incidence of Hemorrhagic Transformation after reperfusion therapy

时间窗: At 24 to 48 hours after reperfusion therapy

Patients will undergo the cranial CT at 24 to 48 hours after reperfusion therapy to identify intracranial hemorrhage

次要结局

  • Incidence of early neurological deterioration(At 24 hours from reperfusion therapy)
  • Incidence of unfavourable short-term prognosis(At 90 days after stroke onset)

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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