Ischemic StrokeNCT06890702
Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease
An observational study of Ischemic Stroke and Ischemic Cerebrovascular Disease, run by Tongji Hospital at 2 sites in China.
Trial summary
The goal of this single-center prospective observational study is to identify and evaluate new biomarkers for ischemic cerebrovascular disease (ICVD) to aid in early diagnosis, individualized treatment planning, and prognosis prediction in affected patients. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Ischemic Cerebrovascular Disease
- What is being tested?
- biomaker levels
- How many people
- 7,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2025to 1 Jan 2038
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ischemic cerebrovascular disease admission to Department of Neurology and Neurosurgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from Janurary 1, 2025 - December 31, 2035
Who may be able to join
- Ischemic cerebrovascular disease has been proved by clinical symptoms and imaging examinations,including transient ischemic attack, cerebral ischemic stroke, steal syndrome, chronic cerebral hypoperfusion, ect al.
- sex and age-matched healthy individuals
Who cannot join
- Brain CT or MRI showing cerebral hemorrhage (excluded ischemic stroke with hemorrhage transformation)
- With severe systemic disease, are expected to survive < 3 months
- Patients will not able to provide continuous follow-up information
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
Wuhan, Hubei, 430030
Daishi Tian, 86-27-83663337, tiands@tjh.tjmu.edu.cn
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
Wuhan, Hubei, 430030
Daishi Tian, 86-27-83663337, tiands@tjh.tjmu.edu.cn
About this study
Official title: A Prospective Observational Cohort Study of Predictive Biomarkers Related With Ischemic Cerebrovascular Disease
The goal of this single-center prospective observational study is to identify and evaluate new biomarkers for ischemic cerebrovascular disease (ICVD) to aid in early diagnosis, individualized treatment planning, and prognosis prediction in affected patients. The main questions it aims to answer are:
Can specific biomarkers help in identifying high-risk individuals before disease onset? Can these biomarkers predict disease progression and treatment response? Researchers will compare patients diagnosed with ICVD and healthy controls from a medical check-up center to assess differences in biomarker expression and their clinical significance.
Read more
Participants will:
Provide blood, cerebrospinal fluid, urine, and stool samples for biomarker analysis.
Undergo clinical imaging (CT, MRI, PET-CT) and functional assessments. Be followed up at 3, 6, 12, 24, 36, and 48 months for clinical outcomes and biomarker changes.
This study aims to develop a comprehensive biomarker-based prediction model to enhance the diagnosis and management of ischemic cerebrovascular disease.
Read the detailed description
The detaited information about this trial is described below
- Quality assurance: The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
- Data check: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data.
- Source data verification: Medical records, electronic case report forms, and imaging would be processed by certified neurologists.
- Conditions
- Ischemic Stroke, Ischemic Cerebrovascular Disease
- Being tested
- biomaker levels
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomaker levelsDiagnostic test
this study will discover and validate novel biomarkers (including urine, feces, cerebrospinal fluid, blood, plaques, emboli, drainage fluid, bone marrow, lymph nodes and brain tissue etc al) of ischemic cerebrovascular disease
| Study group | Role | What they receive |
|---|---|---|
| ischemic cerebrovascular disease | clinical diagnosis with ischemic cerebrovascular disease Receives: Diagnostic Test: biomaker levels | |
| health control | age- and sex-matched control individuals Receives: Diagnostic Test: biomaker levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Death during the follow-up in every single reason
Measured: 10 years
Stroke of any kind
Brain CT or MRI scans will be used to measure whether there is any kind of stroke, including TIA, ischemic stroke, and hemorrhage
Measured: 10 years
Secondary outcomes (3)
Rehospitalization
The rehospitalized times of any circumstances except for admission to hospital only for examination per year will be used to measure the situation
Measured: 10 years
National Institute of Health stroke scale (NIHSS score)
The minimum value is 0, and maximum value is 42, and higher scores mean a worse outcome.
Measured: 10 years
modified Ranking score (mRS)
The minimum value is 0, and maximum value is 6, and higher scores mean a worse outcome.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Jan 2025
- Primary completion27 Dec 2035 (estimated)
- Study completion1 Jan 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daishi Tian, Tongji Hospital
- Investigators
- Dai-Shi Tian, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890702
- Sponsor's protocol ID
- TJ-IRB202509068
- Status last verified
- Jul 2026
- First submitted
- 17 Mar 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study of Predictive Biomarkers Related With Ischemic Cerebrovascular Disease
- ClinicalTrials.gov ID
- NCT06890702
- Acronym / sponsor ID
- TJ-IRB202509068
- Conditions
- Ischemic Stroke, Ischemic Cerebrovascular Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 27 Dec 2035 (estimated)
- Study completion
- 1 Jan 2038 (estimated)
- First posted
- 24 Mar 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.
The goal of this single-center prospective observational study is to identify and evaluate new biomarkers for ischemic cerebrovascular disease (ICVD) to aid in early diagnosis, individualized treatment planning, and prognosis prediction in affected patients. The main questions it aims to answer are:
Can specific biomarkers help in identifying high-risk individuals before disease onset? Can these biomarkers predict disease progression and treatment response? Researchers will compare patients diagnosed with ICVD and healthy controls from a medical check-up center to assess differences in biomarker expression and their clinical significance.
Participants will:
Provide blood, cerebrospinal fluid, urine, and stool samples for biomarker analysis.
Undergo clinical imaging (CT, MRI, PET-CT) and functional assessments. Be followed up at 3, 6, 12, 24, 36, and 48 months for clinical outcomes and biomarker changes.
This study aims to develop a comprehensive biomarker-based prediction model to enhance the diagnosis and management of ischemic cerebrovascular disease.
Detailed description
The detaited information about this trial is described below
- Quality assurance: The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
- Data check: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data.
- Source data verification: Medical records, electronic case report forms, and imaging would be processed by certified neurologists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ischemic cerebrovascular disease | – | Diagnostic Test: biomaker levelsclinical diagnosis with ischemic cerebrovascular disease |
| health control | – | Diagnostic Test: biomaker levelsage- and sex-matched control individuals |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic cerebrovascular disease admission to Department of Neurology and Neurosurgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from Janurary 1, 2025 - December 31, 2035
Key inclusion criteria (2 listed)
- Ischemic cerebrovascular disease has been proved by clinical symptoms and imaging examinations,including transient ischemic attack, cerebral ischemic stroke, steal syndrome, chronic cerebral hypoperfusion, ect al.
- sex and age-matched healthy individuals
Key exclusion criteria (3 listed)
- Brain CT or MRI showing cerebral hemorrhage (excluded ischemic stroke with hemorrhage transformation)
- With severe systemic disease, are expected to survive < 3 months
- Patients will not able to provide continuous follow-up information
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 |
|---|---|---|
| biomaker levelsthis study will discover and validate novel biomarkers (including urine, feces, cerebrospinal fluid, blood, plaques, emboli, drainage fluid, bone marrow, lymph nodes and brain tissue etc al) of ischemic cerebrovascular disease | Diagnostic test | health control, ischemic cerebrovascular disease |
Primary outcome
all-cause mortality
Time frame: 10 years
Death during the follow-up in every single reason
Stroke of any kind
Time frame: 10 years
Brain CT or MRI scans will be used to measure whether there is any kind of stroke, including TIA, ischemic stroke, and hemorrhage
3 secondary outcomes
Rehospitalization
Time frame: 10 years
National Institute of Health stroke scale (NIHSS score)
Time frame: 10 years
modified Ranking score (mRS)
Time frame: 10 years
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 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Dai-Shi Tian principal investigator
Tongji Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Ischemic Cerebrovascular Disease, run by Tongji Hospital at 2 sites 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 2 inclusion and 3 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 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Luo-Qi Zhou (86-27-83663337, zhouluoqi@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 10 years). The study lists 2 primary outcomes in all. 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 28 Jul 2026.