Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorTongji Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

7,000 Participants
are divided into 2 treatment groups
Group A: ischemic cerebrovascular disease1 intervention
Group B: health control1 intervention

Trial outcomes

Primary outcomes

1

all-cause mortality

Death during the follow-up in every single reason

Time frame
10 years
2

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

Time frame
10 years

Secondary outcomes

1

Rehospitalization

The rehospitalized times of any circumstances except for admission to hospital only for examination per year will be used to measure the situation

Time frame
10 years
2

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.

Time frame
10 years
3

modified Ranking score (mRS)

The minimum value is 0, and maximum value is 6, and higher scores mean a worse outcome.

Time frame
10 years

Other outcomes

Sponsors and contacts

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