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NCT Number: NCT07003477

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

Location status: Recruiting

Location contact

Chen Chen, MD, PhD

CONTACT

[email protected]

86 15921119641

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Detection of peripheral blood biomarkers

Diagnostic Test

Peripheral blood samples were collected from patients suffering from acute stroke. The concentration of the biomarker glial fibrillary acidic protein (GFAP) was then detected. This was aimed at differentiating between hemorrhagic stroke and non - hemorrhagic stroke. Time - concentration curves were constructed, thereby offering a novel potential approach for the rapid identification of stroke types within ambulances.

Primary outcomes

  1. stroke subtype

    Time frame: Upon arrival at the hospital for the first time

    Cerebral hemorrhage diagnosed by head CT

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Collaborators

  • Fudan University
  • Huashan Hospital
  • Shanghai 7th People's Hospital
  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital
  • Shanghai Zhongshan Hospital

Registry information

Official study title

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

Acronym: Bio-EAST

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 4, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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