Cerebral Large Vessel Occlusion Stroke Multiomics Biosample Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Number of patients with futile recanalization
研究概览
简要总结
This multicenter, ambispective cohort study establishes a comprehensive multiomics biobank from five stroke centers, encompassing thrombi, intracranial blood, peripheral arterial/venous blood, and clinical-laboratory-imaging-follow-up data from patients with acute ischemic stroke with large vessel occlusion (AIS-LVO).
详细描述
This study is a multicenter, ambispective cohort study. Blood clot, peripheral arterial blood, peripheral venous blood, and intracranial blood samples were collected from patients at 5 stroke centers to establish a biobank of patients with AIS-LVO.
Blood and thrombus samples underwent pathological analysis, metabolomics, proteomics, and genomics for multidimensional testing. Additionally, clinical, laboratory, follow-up, and imaging data were collected.
The main objective is to identify phenotypic differences between intracranial blood and peripheral blood, describe the microenvironment profile, and perform a combined analysis of the thrombus' multi-omics phenotypes to construct a "microenvironment" multiomics fingerprint.
Furthermore, based on the multi-omics phenotypic components of thrombus and blood, clinical prediction models will be built. These models will address clinical issues related to etiology diagnosis, risk stratification, and prognosis in large vessel occlusion stroke patients, using external or internal validation methods.
For a subset of patients, thrombus samples will undergo pathological processing and histological examination, followed by joint analysis with multi-omics data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years.
- •Patients with intracranial and extracranial large vessel occlusion ischemic stroke confirmed by cerebrovascular angiography.
- •Availability of complete clinical and follow-up information required for the study.
- •Availability of blood and/or thrombus biological samples.
- •Voluntary written informed consent signed by the patient or their family (1) For retrospectively enrolled patients, a "broad informed consent" was signed at the time of sample collection. Upon enrollment into the cohort, a follow-up phone call was made to confirm the informed consent.
- •(2) For prospectively enrolled patients, informed consent for this study was signed at the time of enrollment by the patient or their family.
排除标准
- •Patients for whom biological samples cannot be obtained;
- •Patients or their family members who refuse to sign the informed consent form.
结局指标
主要结局
Number of patients with futile recanalization
时间窗: From enrollment to 3 month follow-up
mRS score ≥3 at 3 months
次要结局
- Number of patients with specific stroke etiologies(Baseline)
- Number of patients with hemorrhagic transformation(7 days within stroke onset)
- Number of patients with infarct expansion(Baseline)
研究者
Jie Xu
Deputy Director
First Affiliated Hospital of Wannan Medical College