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

NCT07003477 | Recruiting

• 1 other identifier: Bio-EAST
• Study Type: observational
• Target: 527
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; Intracerebral hemorrhage; GFAP (glial fibrillary acidic protein); Pre-hospital diagnosis

Outcome Measures

Primary Outcomes (1)

• stroke subtype

  Cerebral hemorrhage diagnosed by head CT

  Upon arrival at the hospital for the first time

Study Arms (2)

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.

Diagnostic Test: Detection of peripheral blood biomarkers

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.

Diagnostic Test: Detection of peripheral blood biomarkers

Interventions

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.

Non-hemorrhagic stroke; intracranial hemorrhage, ICH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This project plans to collect 2 cases per week from each participating medical center (such as Shanghai East Hospital, Zhongshan Hospital, and Huashan Hospital). We anticipate enrolling at least 527 patients. Blood samples will be collected from each patient at 2 time points, resulting in approximately 1,054 specimens in total.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai East Hospital: lead
• Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University: collaborator
• Shanghai 7th People's Hospital: collaborator
• Huashan Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Fudan University: collaborator

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human peripheral blood plasma

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gang Li

CONTACT

+86 136 2169 1786; ligang@tongji.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: January 21, 2026

Record last verified: 2025-05

Locations

CN (1)