Predictors and Prognostic Factors on the Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-03

Study Completion Date

2022-09-01

Brief Summary

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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.

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Detailed Description

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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

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Drug Therapy

Intervention Type DRUG

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

Routine Blood Test and Image Scan

Intervention Type DIAGNOSTIC_TEST

Routine blood test(HCY, LDL and ect.) and image scan (DWI, DSA and ect.)

Intravascular therapy

Intervention Type OTHER

Intravascular therapy including thrombectomy

Emergency Treatment

Intervention Type OTHER

Emergency treatment including time to self-diagnosis of stroke, time to call for help, devices used to hospital and ect.

Medical history

Intervention Type OTHER

Medical history including hypertension, diabetes, hyperlipemia and ect.

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.

Routine Blood Test and Image Scan

Intervention Type DIAGNOSTIC_TEST

Routine blood test(HCY, LDL and ect.) and image scan (DWI, DSA and ect.)

Medical history

Intervention Type OTHER

Medical history including hypertension, diabetes, hyperlipemia and ect.

Interventions

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Drug Therapy

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

Intervention Type DRUG

Routine Blood Test and Image Scan

Routine blood test(HCY, LDL and ect.) and image scan (DWI, DSA and ect.)

Intervention Type DIAGNOSTIC_TEST

Intravascular therapy

Intravascular therapy including thrombectomy

Intervention Type OTHER

Emergency Treatment

Emergency treatment including time to self-diagnosis of stroke, time to call for help, devices used to hospital and ect.

Intervention Type OTHER

Medical history

Medical history including hypertension, diabetes, hyperlipemia and ect.

Intervention Type OTHER

Other Intervention Names

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Aspirin Clopidogrel Statin

Eligibility Criteria

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Inclusion Criteria

* ≥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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No