Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease

Tongji Hospital

Status

Enrolling

Conditions

Ischemic Stroke

Ischemic Cerebrovascular Disease

Treatments

Diagnostic Test: biomaker levels

Study type

Observational

Funder types

Other

Identifiers

NCT06890702

TJ-IRB202509068

Details and patient eligibility

About

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.

Full 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.

Enrollment

7,000 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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