Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Ischemic Cerebrovascular Disease
• Intervention / Treatment: Diagnostic test: biomaker levels

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 Type: Observational
• Enrollment (Estimated): 7000

Contacts and Locations

• Study Contact: Name: Luo-Qi Zhou; Phone Number: 86-27-83663337; Email: zhouluoqi@tjh.tjmu.edu.cn
• Study Contact Backup: Name: Xiaowei Pang; Phone Number: 86-27-83663337; Email: pangxiaowei1998@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Not yet recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
      • Contact: Daishi Tian; Phone Number: 86-27-83663337; Email: tiands@tjh.tjmu.edu.cn
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
      • Contact: Daishi Tian; Phone Number: 86-27-83663337; Email: tiands@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with ischemic cerebrovascular disease admission to Department of Neurology and Neurosurgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from Janurary 1, 2025 - December 31, 2035

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
health control; age- and sex-matched control individuals	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
ischemic cerebrovascular disease; clinical diagnosis with ischemic cerebrovascular disease	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	Death during the follow-up in every single reason	10 years
Stroke of any kind	Brain CT or MRI scans will be used to measure whether there is any kind of stroke, including TIA, ischemic stroke, and hemorrhage	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehospitalization	The rehospitalized times of any circumstances except for admission to hospital only for examination per year will be used to measure the situation	10 years
National Institute of Health stroke scale (NIHSS score)	The minimum value is 0, and maximum value is 42, and higher scores mean a worse outcome.	10 years
modified Ranking score (mRS)	The minimum value is 0, and maximum value is 6, and higher scores mean a worse outcome.	10 years

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Dai-Shi Tian, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 27, 2035
• Study Completion (Estimated): January 1, 2038

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: TJ-IRB202509068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No