StrokeBio-EASTNCT07003477
Biomarkers Based EArly Diagnosis of STroke Subtype Cohort（Bio-EAST）
An observational study of Stroke, run by Shanghai East Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Detection of peripheral blood biomarkers
- How many people
- 527 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2025to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123
Chen Chen, MD, PhD, 86 15921119641, 15921119641@163.com
About this study
Official title: Biomarkers Based EArly Diagnosis of STroke Subtype Cohort, Bio-EAST
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.
- Conditions
- Stroke
- Being tested
- Detection of peripheral blood biomarkers
- Keywords
- stroke, Intracerebral hemorrhage, GFAP (glial fibrillary acidic protein), Pre-hospital diagnosis
- Medical subject headings
- Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of peripheral blood biomarkersDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| intracranial hemorrhage, ICH | Patients diagnosed with hemorrhagic stroke by clinical gold standard. Detect the peripheral blood biomarkers，and the results were compared with the clinical gold standard. Receives: Diagnostic Test: Detection of peripheral blood biomarkers | |
| Non-hemorrhagic stroke | Patients diagnosed with non-hemorrhagic stroke by clinical gold standard. Detect the peripheral blood biomarkers，and the results were compared with the clinical gold standard. Receives: Diagnostic Test: Detection of peripheral blood biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke subtype
Cerebral hemorrhage diagnosed by head CT
Measured: Upon arrival at the hospital for the first time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start12 Jun 2025
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 527 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 7th People's Hospital, Huashan Hospital, Shanghai Zhongshan Hospital, Fudan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003477
- Sponsor's protocol ID
- Bio-EAST
- Acronym
- Bio-EAST
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers Based EArly Diagnosis of STroke Subtype Cohort, Bio-EAST
- ClinicalTrials.gov ID
- NCT07003477
- Acronym / sponsor ID
- Bio-EAST / Bio-EAST
- Conditions
- Stroke
- Keywords
- stroke, Intracerebral hemorrhage, GFAP (glial fibrillary acidic protein), Pre-hospital diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 527 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 7th People's Hospital, Huashan Hospital, Shanghai Zhongshan Hospital, Fudan University
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intracranial hemorrhage, ICH | – | Diagnostic Test: Detection of peripheral blood biomarkersPatients diagnosed with hemorrhagic stroke by clinical gold standard. Detect the peripheral blood biomarkers，and the results were compared with the clinical gold standard. |
| Non-hemorrhagic stroke | – | Diagnostic Test: Detection of peripheral blood biomarkersPatients diagnosed with non-hemorrhagic stroke by clinical gold standard. Detect the peripheral blood biomarkers，and the results were compared with the clinical gold standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of peripheral blood biomarkersPeripheral 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. | Diagnostic test | Non-hemorrhagic stroke, intracranial hemorrhage, ICH |
Primary outcome
stroke subtype
Time frame: Upon arrival at the hospital for the first time
Cerebral hemorrhage diagnosed by head CT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang Li (+86 136 2169 1786, ligang@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke subtype (time frame: Upon arrival at the hospital for the first time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.