Clinical trial NCT06890702: Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease
Official title: A Prospective Observational Cohort Study of Predictive Biomarkers Related With Ischemic Cerebrovascular Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ischemic Stroke
Ischemic Cerebrovascular Disease
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: all-cause mortality
timeFrame: 10 years
measure: Stroke of any kind
timeFrame: 10 years
Secondary outcomes:
measure: Rehospitalization
timeFrame: 10 years
measure: National Institute of Health stroke scale (NIHSS score)
timeFrame: 10 years
measure: modified Ranking score (mRS)
timeFrame: 10 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Dai-Shi Tian
role: PRINCIPAL_INVESTIGATOR
References: