A Prospective Cohort Study of Predictors and Prognostic Factors on the Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale scores
研究概览
简要总结
Through 5 years continuous observation of acute ischemic stroke patients in Neurology Department of Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, clinical data about emergency treatment (neurological score, examination and treatment), medical data after admission (neurological score, inspection, examination and treatment) and long-term prognosis (neurological score) was collected. The outcomes were set as the score scale, all blood test index and examination index of the research objects at specific period after illness. Through statistical analysis and comparison of different in-hospital clinical data in predicting the outcome of the patients, our study will provide more evidence-based solutions for the treatment and prediction of acute ischemic stroke.
详细描述
The research is designed as registrated, prospective, open-labeled, blind-endpoint, and the research objects are continuously recorded. The final subgroups are blind to neurological evaluators, data inputers and statisticians.
The research is a continuous observational exploratory study. All patients with ischemic stroke admitted to Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology from April 1, 2017 to December 31, 2021 will be included. According to the current situation, it is expected to enroll approximately 5000 of eligible patients for long-term follow-up observation.
We'll use multiple linear regression analysis model to study factors and confounding factors and their interaction. And we will control the confounding factors, and make a quantitative description of the relationship between factors and outcome variables.
Missing cases will be treated as censored values, and the ratio of missing cases will be recorded. All samples will be analyzed by Intent-to-Treat (ITT) analysis. In the analysis, if the results are statistically significant, the missing cases in the exposed group will be deleted, and the missing cases in non-exposure group be added. If the results are still statistically significant, then the missing cases are defined as not affecting the analysis results.
If the heterogeneity of data is large, the objects will be analyzed in subgroups according to age or sex.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old, of either sex
- •Confirmation by CT scan
- •Willingness to participate in the study and comply with its procedures by signing a written informed consent
排除标准
- •Cerebral hemorrhagic infarction confirmed by CT scan
- •Patients with severe systemic disease who are expected to survive for no more than three months
- •Unwilling to participate in the study
研究组 & 干预措施
Patients With Ischemic Stroke
The patients with all types of ischemic stroke including TIA, small vessle diseases, MCAO, and ect. These patients will be recorded their emergency treatment, medical history, details about their drug therapy, results of their routine blood test and image scan, and whether they receive intravascular therapy in time or not.
干预措施: Drug Therapy (Drug)
Patients With Ischemic Stroke
The patients with all types of ischemic stroke including TIA, small vessle diseases, MCAO, and ect. These patients will be recorded their emergency treatment, medical history, details about their drug therapy, results of their routine blood test and image scan, and whether they receive intravascular therapy in time or not.
干预措施: Routine Blood Test and Image Scan (Diagnostic Test)
Patients With Ischemic Stroke
The patients with all types of ischemic stroke including TIA, small vessle diseases, MCAO, and ect. These patients will be recorded their emergency treatment, medical history, details about their drug therapy, results of their routine blood test and image scan, and whether they receive intravascular therapy in time or not.
干预措施: Intravascular therapy (Other)
Patients With Ischemic Stroke
The patients with all types of ischemic stroke including TIA, small vessle diseases, MCAO, and ect. These patients will be recorded their emergency treatment, medical history, details about their drug therapy, results of their routine blood test and image scan, and whether they receive intravascular therapy in time or not.
干预措施: Emergency Treatment (Other)
Patients With Ischemic Stroke
The patients with all types of ischemic stroke including TIA, small vessle diseases, MCAO, and ect. These patients will be recorded their emergency treatment, medical history, details about their drug therapy, results of their routine blood test and image scan, and whether they receive intravascular therapy in time or not.
干预措施: Medical history (Other)
Healthy Control
The patients admitted to hospital for symptoms like dizzness and headache, which later proved to be not related to cerebral vascular diseases, would be treated as control. Their medical history and the results of their routine blood test and image scan will be recorded.
干预措施: Routine Blood Test and Image Scan (Diagnostic Test)
Healthy Control
The patients admitted to hospital for symptoms like dizzness and headache, which later proved to be not related to cerebral vascular diseases, would be treated as control. Their medical history and the results of their routine blood test and image scan will be recorded.
干预措施: Medical history (Other)
结局指标
主要结局
Modified Rankin Scale scores
时间窗: Change from Baseline mRS score at 24 months
0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead.
次要结局
- Re-admission to the hospital(24 months)
- Cerebral and Cardio vascular diseases(24 months)
- Neurological deterioration-2(Change from Baseline FAQ score at 24 months)
- Cognitive dysfunction(Change from Baseline MoCA score at 24 months)
- Neurological deterioration-1(Change from Baseline NIHSS score at 24 months)
- Cerebrospinal Fluid (CSF) test(24 months)
- Severe pulmonary infection(24 months)
- Blood test(24 months)
- Depression(24 months)
研究者
Wei Wang
Vice President of Tongji Hospital
Tongji Hospital