NCT07003477Recruiting
Biomarkers Based EArly Diagnosis of STroke Subtype Cohort（Bio-EAST）
Biomarkers Based EArly Diagnosis of STroke Subtype Cohort, Bio-EAST
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 527 (estimated)
- First submitted
- 26 May 2025
- Start date
- 12 Jun 2025
- Primary completion date
- 30 Aug 2028
- Lead sponsor
- Shanghai East Hospital
- Diseases
- Stroke
- NCT number
- NCT07003477
What you commit to
- Study type: Observational
- Planned participants: 527
- From 12 Jun 2025 to the primary completion date, 30 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
Lab values
- Blood glucose \< 2.8 mmol/L.
Other
- Coma - no response to tactile or verbal stimuli;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.