Clinical trial NCT07003477: Biomarkers Based EArly Diagnosis of STroke Subtype Cohort（Bio-EAST）
Official title: Biomarkers Based EArly Diagnosis of STroke Subtype Cohort, Bio-EAST
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Keywords: stroke
Intracerebral hemorrhage
GFAP (glial fibrillary acidic protein)
Pre-hospital diagnosis
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University
name: Shanghai 7th People's Hospital
name: Huashan Hospital
name: Shanghai Zhongshan Hospital
name: Fudan University
First posted: 2025-06-04
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This project plans to collect 2 cases per week from each participating medical center (such as Shanghai East Hospital, Zhongshan Hospital, and Huashan Hospital). We anticipate enrolling at least 527 patients. Blood samples will be collected from each patient at 2 time points, resulting in approximately 1,054 specimens in total.

Brief 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 criteria: Inclusion Criteria:

1. Age ≥ 18 years old;
2. Suspected stroke at emergency department arrival (FAST score ≥ 2 points, must include limb weakness);
3. Time of stroke symptom onset/last known normal within 3 hours.

Exclusion Criteria:

1. Coma - no response to tactile or verbal stimuli;
2. Severe comorbidities (such as tumors, severe COPD, severe heart failure, requiring assistance with daily living \[unable to walk independently\]);
3. History of epilepsy or onset with seizure;
4. Recent history of head trauma (\< 7 days);
5. Blood glucose \< 2.8 mmol/L.

Primary outcomes:
measure: stroke subtype
timeFrame: Upon arrival at the hospital for the first time
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
References: