Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease

NCT06890702 | Recruiting

• 1 other identifier: TJ-IRB202509068
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischemic Stroke; Ischemic Cerebrovascular Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Rehospitalization

  10 years

• National Institute of Health stroke scale (NIHSS score)

  10 years

• modified Ranking score (mRS)

  10 years

Study Arms (2)

ischemic cerebrovascular disease

clinical diagnosis with ischemic cerebrovascular disease

Diagnostic Test: biomaker levels

health control

age- and sex-matched control individuals

Diagnostic Test: biomaker levels

Interventions

biomaker levels DIAGNOSTIC_TEST

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

health control; ischemic cerebrovascular disease

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (2)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Collect samples of urine, fecal, cerebrospinal fluid, blood, plaques, emboli, drainage fluid, bone marrow, lymph nodes, pia mater, dura mater and brain tissue etc.al from patients

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dai-Shi Tian

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luo-Qi Zhou

CONTACT

86-27-83663337; zhouluoqi@tjh.tjmu.edu.cn

Xiaowei Pang

CONTACT

86-27-83663337; pangxiaowei1998@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 24, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 27, 2035
• Study Completion (Estimated): January 1, 2038
• Last Updated: December 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)