Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• all-cause mortality [Срок оценки: 10 years]
• Stroke of any kind [Срок оценки: 10 years]

Вторичные конечные точки (3)

• Rehospitalization [Срок оценки: 10 years]
• National Institute of Health stroke scale (NIHSS score) [Срок оценки: 10 years]
• modified Ranking score (mRS) [Срок оценки: 10 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, — Ухань
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, — Ухань

Идентификаторы

NCT: NCT06890702 · TJ-IRB202509068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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