Biomarkers Based EArly Diagnosis of STroke Subtype Cohort（Bio-EAST）
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Detection of peripheral blood biomarkers.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Biomarkers Based EArly Diagnosis of STroke Subtype Cohort, Bio-EAST
Overview
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.
Interventions
- Diagnostic test Detection of peripheral blood biomarkers
Peripheral blood samples were collected from patients suffering from acute stroke. The concentration of the biomarker glial fibrillary acidic protein (GFAP) was then detected. This was aimed at differentiating between hemorrhagic stroke and non - hemorrhagic stroke. Time - concentration curves were constructed, thereby offering a novel potential approach for the rapid identification of stroke types within ambulances.
Primary outcome measures
- stroke subtype [Time frame: Upon arrival at the hospital for the first time]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Shanghai East Hospital — Shanghai
Identifiers
NCT: NCT07003477 · Bio-EAST