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

ConditionStroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai East Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Detection of peripheral blood biomarkers

Treatment groups

527 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai East Hospital

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Collaborator

Shanghai 7th People's Hospital

Collaborator

Huashan Hospital

Collaborator

Shanghai Zhongshan Hospital

Collaborator

Fudan University

Collaborator