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

NCT ID: NCT07003477

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 527 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-12
• Study Completion Date: 2028-11-30

Brief Summary

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.

Conditions

Stroke

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

intracranial hemorrhage, ICH

Patients diagnosed with hemorrhagic stroke by clinical gold standard. Detect the peripheral blood biomarkers，and the results were compared with the clinical gold standard.

Detection of peripheral blood biomarkers

Intervention Type: 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.

Non-hemorrhagic stroke

Patients diagnosed with non-hemorrhagic stroke by clinical gold standard. Detect the peripheral blood biomarkers，and the results were compared with the clinical gold standard.

Detection of peripheral blood biomarkers

Intervention Type: 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.

Interventions

Detection of peripheral blood biomarkers

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University

UNKNOWN

Sponsor Role: collaborator

Shanghai 7th People's Hospital

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Shanghai East Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Gang Li

Role: CONTACT

ligang@tongji.edu.cn

+86 136 2169 1786

Facility Contacts

Chen Chen, MD, PhD

Role: primary

15921119641@163.com

86 15921119641

Other Identifiers

Bio-EAST

Identifier Type: -

Identifier Source: org_study_id