Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease

Not yet recruiting

• Conditions: Ischemic Stroke; Ischemic Cerebrovascular Disease

• Registration Number: NCT06890702
• Lead Sponsor: Tongji Hospital

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-17
• Study First Posted: 2025-03-24
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Study Start: 2025-05-01
• Primary Completion: 2035-12-27
• Study Completion: 2038-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 7000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,; 🇨🇳 Wuhan, Hubei, China