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临床试验/NCT06383182
NCT06383182招募中不适用

Change in Serum Biomarkers After Endovascular Treatment for Acute Anterior Circulation Large Vessel Occlusion: a Prospective, Registry Study

General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Dynamic changes in serum biomarkers after endovascular treatment

研究概览

简要总结

Acute ischaemic stroke (AIS) results in high rates of neurological morbidity and mortality, especially in patients with large vessel occlusion (LVO). Endovascular therapy (EVT) has been approved as the most effective treatment for patients with LVO , but about half patients undergoing EVT did not achieve good outcome. The mechanisms of poor prognosis are complex. How to accurately identify serological biomarkers related to patients' clinical prognosis is an important research topic nowadays.

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

入选标准

  • Age: 18-80 years;
  • Patients with acute anterior circulation large vessel occlusion within 24 hours of onset who will receive endovascular treatment;
  • Pre-stroke mRS: 0-1;
  • Baseline NIHSS: ≥6;
  • Signed informed consent.

排除标准

  • The presence of contraindications to internal jugular vein cannulation;
  • Receiving intravenous thrombolysis;
  • Haemorrhagic stroke (cerebral haemorrhage or subarachnoid haemorrhage);
  • Coagulation disorders, systemic bleeding tendency, thrombocytopenia (<100×109/L);
  • Severe cardiac, hepatic or renal insufficiency (ALT or AST elevated more than 2 times the upper limit of normal value, or serum creatinine elevated more than 1.5 times the upper limit of normal value or in need of dialysis) or other serious medical diseases;
  • Severe uncontrolled hypertension (systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg);
  • Pregnant or lactating women;
  • Other conditions who are not suitable for this trial by investigator.

结局指标

主要结局

Dynamic changes in serum biomarkers after endovascular treatment

时间窗: from the baseline to immediately, 30 minutes, 6 hours, and 24 hours after endovascular treatment

These biomarkers will be identified based on proteomic methods

次要结局

  • favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2(90±7 days)
  • distribution of modified Rankin Scale (mRS) score(90±7 days)
  • early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS)(24±8 hours)
  • occurence of new stroke or other vascular events(90±7 days)
  • excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1(90±7 days)
  • changes in National Institute of Health stroke scale (NIHSS)(24±8 hours)
  • symptomatic intracranial hemorrhage (sICH)(24±8 hours)

研究者

发起方
General Hospital of Shenyang Military Region
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hui-Sheng Chen

Director

General Hospital of Shenyang Military Region

研究点 (1)

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