New biomarkers for ischemic cerebrovascular disease
A Prospective Observational Cohort Study of Predictive Biomarkers Related With Ischemic Cerebrovascular Disease
This study will test whether specific blood, cerebrospinal fluid, urine, and stool biomarkers can help diagnose and predict outcomes for people with ischemic stroke and related cerebrovascular conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 7000 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 2 sites (Wuhan, Hubei and 1 other locations) |
| Trial ID | NCT06890702 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective observational study that compares patients with ischemic cerebrovascular disease to age- and sex-matched healthy controls from a medical check-up center. Participants provide blood, cerebrospinal fluid, urine, and stool samples, undergo clinical imaging (CT, MRI, PET-CT) and functional assessments, and are followed at 3, 6, 12, 24, 36, and 48 months to track clinical outcomes and biomarker changes. Researchers will analyze biomarker expression differences and combine clinical and laboratory data to build a prediction model for diagnosis, progression, and treatment response. Data access is governed by an independent review panel and secure data-sharing agreements, with source data verified by certified neurologists.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with ischemic cerebrovascular disease (including TIA, ischemic stroke, chronic cerebral hypoperfusion, or related conditions) or age- and sex-matched healthy volunteers who can provide biological samples and attend scheduled follow-ups.
Not a fit: Patients with cerebral hemorrhage, those with severe systemic disease expected to survive less than three months, or those unable to provide ongoing follow-up are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the findings could enable earlier diagnosis, more individualized treatment planning, and better prognosis prediction for people with ischemic cerebrovascular disease.
How similar studies have performed: Previous biomarker research in stroke has produced some promising but inconsistent results, so similar approaches are plausible but not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Wuhan, Hubei and 1 other locations
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, — Wuhan, Hubei, China (Not_yet_recruiting)
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Dai-Shi Tian — Tongji Hospital
- Study coordinator: Luo-Qi Zhou
- Email: zhouluoqi@tjh.tjmu.edu.cn
- Phone: 86-27-83663337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.