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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Diagnostic test: Detection of peripheral blood biomarkers

• Study Type: Observational
• Enrollment (Estimated): 527

Contacts and Locations

• Study Contact: Name: Gang Li; Phone Number: +86 136 2169 1786; Email: ligang@tongji.edu.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200123
      • Recruiting
      • Shanghai East Hospital
      • Contact: Chen Chen, MD, PhD; Phone Number: 86 15921119641; Email: 15921119641@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stroke subtype	Cerebral hemorrhage diagnosed by head CT	Upon arrival at the hospital for the first time

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2025
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: May 26, 2025
• First Submitted That Met QC Criteria: May 26, 2025
• First Posted (Actual): June 4, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: stroke; Intracerebral hemorrhage; GFAP (glial fibrillary acidic protein); Pre-hospital diagnosis
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Stroke; Cerebral Hemorrhage
• Other Study ID Numbers: Bio-EAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No