Predictors and Prognostic Factors on the Acute Ischemic Stroke

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

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.
If the missing rate is greater than 20%, it is necessary to analyze the sensitivity of the whole sample.

Conditions

Interventions

  • Drug Therapy Drug
    Other Names: Aspirin; Clopidogrel; Statin
    Intervention Desc: For this observation research, anti platelet drugs, statins and ect. would be used as clinical guidelines as usal, and statical ananysis of the relationship between these drugs and the final outcomes
    ARM 1: Kind: Experimental
    Label: Patients With Ischemic Stroke
    Description: 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.
  • Routine Blood Test and Image Scan Diagnostic Test
    Intervention Desc: Routine blood test(HCY, LDL and ect.) and image scan (DWI, DSA and ect.)
    ARM 1: Kind: Experimental
    Label: Patients With Ischemic Stroke
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Healthy Control
    Description: 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.
  • Intravascular therapy Other
    Intervention Desc: Intravascular therapy including thrombectomy
    ARM 1: Kind: Experimental
    Label: Patients With Ischemic Stroke
    Description: 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.
  • Emergency Treatment Other
    Intervention Desc: Emergency treatment including time to self-diagnosis of stroke, time to call for help, devices used to hospital and ect.
    ARM 1: Kind: Experimental
    Label: Patients With Ischemic Stroke
    Description: 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.
  • Medical history Other
    Intervention Desc: Medical history including hypertension, diabetes, hyperlipemia and ect.
    ARM 1: Kind: Experimental
    Label: Patients With Ischemic Stroke
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Healthy Control
    Description: 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.

Trial Population

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Scale scores Change from Baseline mRS score at 24 months
Secondary Re-admission to the hospital 24 months
Secondary Cerebral and Cardio vascular diseases 24 months
Secondary Neurological deterioration-1 Change from Baseline NIHSS score at 24 months
Secondary Neurological deterioration-2 Change from Baseline FAQ score at 24 months
Secondary Cognitive dysfunction Change from Baseline MMSE score at 24 months
Secondary Cerebrospinal Fluid (CSF) test 24 months
Secondary Blood test 24 months
Secondary Depression 24 months
Secondary Severe pulmonary infection 24 months

Biospecimen Retention:Samples With DNA - blood sample

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