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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai East Hospital
RECRUITING
Shanghai
Contact Information
Primary
Gang Li
ligang@tongji.edu.cn
+86 136 2169 1786
Time Frame
Start Date: 2025-06-12
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 527
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Shanghai East Hospital
Collaborators: Shanghai 7th People's Hospital, Fudan University, Huashan Hospital, Shanghai Zhongshan Hospital, Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University

This content was sourced from clinicaltrials.gov