Ischemic Cerebrovascular Disease, Ischemic Stroke
Conditions
Brief 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. 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 1. 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. 2. Data check: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. 3. Source data verification: Medical records, electronic case report forms, and imaging would be processed by certified neurologists.
Interventions
DIAGNOSTIC_TESTbiomaker levels
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
Sponsors
Tongji Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| all-cause mortality | 10 years | Death during the follow-up in every single reason |
| Stroke of any kind | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rehospitalization | 10 years | The rehospitalized times of any circumstances except for admission to hospital only for examination per year will be used to measure the situation |
| National Institute of Health stroke scale (NIHSS score) | 10 years | The minimum value is 0, and maximum value is 42, and higher scores mean a worse outcome. |
| modified Ranking score (mRS) | 10 years | The minimum value is 0, and maximum value is 6, and higher scores mean a worse outcome. |
Countries
China
Contacts
CONTACTLuo-Qi Zhou
CONTACTXiaowei Pang
PRINCIPAL_INVESTIGATORDai-Shi Tian
Tongji Hospital
Outcome results
None listed