跳至主要内容
临床试验/NCT07003477
NCT07003477招募中不适用

Biomarkers Based EArly Diagnosis of STroke Subtype Cohort, Bio-EAST

Shanghai East Hospital1 个研究点 分布在 1 个国家目标入组 527 人开始时间: 2025年6月12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
527
试验地点
1
主要终点
stroke subtype

研究概览

简要总结

Intracerebral hemorrhage carries high rates of mortality and disability, imposes a significant societal burden. Based on findings from our previous multicenter randomized controlled clinical trial (INTERACT4), we revealed that initiating intensive blood pressure reduction therapy within 2 hours of onset in ambulances can markedly enhance the prognosis of patients with intracerebral hemorrhage. Nevertheless, the lack of rapid pre-hospital diagnostic technology hinders its clinical application and promotion. Given that glial fibrillary acidic protein (GFAP), as a biomarker, has been clinically validated for its high specificity in diagnosing intracerebral hemorrhage, this project aims to leverage an industry-academia-research collaborative development model in partnership with Shanghai Jinguan Technology Co., Ltd. By focusing on the urgent need for rapid diagnosis in stroke emergency care, this project will integrate clinical resources from hospitals with technological advantages in product development from the industry. Through resource sharing and complementary strengths, we aim to develop GFAP rapid detection technology with single-molecule sensitivity utilizing internationally advanced silicon photonics technology. Our objectives further include establishing a Chinese cohort to validate the reliability of GFAP in diagnosing intracerebral hemorrhage and conducting multicenter randomized controlled clinical trials to ascertain the efficacy and safety of GFAP-guided pre-hospital intensive blood pressure reduction for patients with intracerebral hemorrhage. This study also aimed to explore other biomarkers to be combined with GFAP in order to improve its sensitivity in detecting ICH.

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

  • Age ≥ 18 years old;
  • Suspected stroke at emergency department arrival (FAST score ≥ 2 points, must include limb weakness);
  • Time of stroke symptom onset/last known normal within 3 hours.

排除标准

  • Coma - no response to tactile or verbal stimuli;
  • Severe comorbidities (such as tumors, severe COPD, severe heart failure, requiring assistance with daily living [unable to walk independently]);
  • History of epilepsy or onset with seizure;
  • Recent history of head trauma (< 7 days);
  • Blood glucose < 2.8 mmol/L.

结局指标

主要结局

stroke subtype

时间窗: Upon arrival at the hospital for the first time

Cerebral hemorrhage diagnosed by head CT

次要结局

未报告次要终点

研究者

发起方
Shanghai East Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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