Biomarkers Based EArly Diagnosis of STroke Subtype Cohort（Bio-EAST）
Recruiting now
Conditions studied: Stroke
In brief
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.
Key facts
- Study ID
- NCT07003477
- Run by
- Shanghai East Hospital
- People needed
- 527
- Starts
- 2025-06-12
- Expected to finish
- 2028-11-30
- Last updated by the study team
- 2026-01-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.