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.

NCT Number	NCT07003477
Lead Sponsor	Shanghai East Hospital Collaborators: Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 7th People's Hospital, Huashan Hospital, Shanghai Zhongshan Hospital, Fudan University
Conditions	Stroke
Enrollment	527 participants
Start Date	2025-06-12
Primary Completion	2028-08-30 (estimated)
Study Completion	2028-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-21