Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease

NCT ID: NCT06890702

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

7000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2038-01-01

Brief Summary

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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

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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

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Ischemic Stroke Ischemic Cerebrovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ischemic cerebrovascular disease

clinical diagnosis with ischemic cerebrovascular disease

biomaker levels

Intervention Type 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

age- and sex-matched control individuals

biomaker levels

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Daishi Tian

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dai-Shi Tian

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Luo-Qi Zhou

Role: CONTACT

86-27-83663337

Xiaowei Pang

Role: CONTACT

86-27-83663337

Facility Contacts

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Daishi Tian

Role: primary

86-27-83663337

Daishi Tian

Role: primary

86-27-83663337

Other Identifiers

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TJ-IRB202509068

Identifier Type: -

Identifier Source: org_study_id

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