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Biomarkers Based EArly Diagnosis of STroke Subtype Cohort（Bio-EAST）

Recruitingn/aAges 18 Years - anyAllShanghai East Hospital
NCT07003477 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥ 18 years old; 2. Suspected stroke at emergency department arrival (FAST score ≥ 2 points, must include limb weakness); 3. Time of stroke symptom onset/last known normal within 3 hours. Exclusion Criteria: 1. Coma - no response to tactile or verbal stimuli; 2. Severe comorbidities (such as tumors, severe COPD, severe heart failure, requiring assistance with daily living \[unable to walk independently\]); 3. History of epilepsy or onset with seizure; 4. Recent history of head trauma (\< 7 days); 5. Blood glucose \< 2.8 mmol/L.
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What it tests

  • Detection of peripheral blood biomarkers
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Where

1 site
Shanghai East Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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