NCT06890702

Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease

A Prospective Observational Cohort Study of Predictive Biomarkers Related With Ischemic Cerebrovascular Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 7,000 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ischemic Stroke
• Ischemic Cerebrovascular Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	biomaker 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

Timeline

• Start date: 2025-01-01
• Primary completion: 2035-12-27
• Completion: 2038-01-01
• First posted: 2025-03-24
• Last updated: 2025-12-09

Locations

2 sites across 1 country: China