Ischemic Stroke
Conditions
Keywords
Ischemic Stroke, Cerebral Infarction, Cerebrovascular Disorders
Brief summary
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.
Interventions
DRUGDrug 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
DIAGNOSTIC_TESTRoutine Blood Test and Image Scan
Routine blood test(HCY, LDL and ect.) and image scan (DWI, DSA and ect.)
OTHERIntravascular therapy
Intravascular therapy including thrombectomy
OTHEREmergency Treatment
Emergency treatment including time to self-diagnosis of stroke, time to call for help, devices used to hospital and ect.
OTHERMedical history
Medical history including hypertension, diabetes, hyperlipemia and ect.
Sponsors
Tongji Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-admission to the hospital | 24 months | Re-admission to the hospital (patients without new symptoms and admitted to the hospital simply for physical examination are not counted) |
| Cerebral and Cardio vascular diseases | 24 months | Cerebral and Cardio vascular diseases including small vessel diseases, white matter ischemia, micro hemorrhage, ischemic stroke and hemorrhagic stroke. |
| Neurological deterioration-1 | Change from Baseline NIHSS score at 24 months | Neurological deterioration (NIHSS score) |
| Neurological deterioration-2 | Change from Baseline FAQ score at 24 months | Neurological deterioration (FAQ score) |
| Cognitive dysfunction | Change from Baseline MMSE score at 24 months | Cognitive dysfunction (MMSE score). Patients with cognitive dysfunction will be classified into mild neurocognitive disorder, major neurocognitive disorder according to DSM-5 |
| Blood test | 24 months | Blood including HCY, amino acid, LDL and ect. |
| Depression | 24 months | Hamilton Depression Scale |
| Severe pulmonary infection | 24 months | Severe pulmonary infection |
| Cerebrospinal Fluid (CSF) test | 24 months | Cerebrospinal Fluid (CSF) test including Tau, Aβ and ect. |
Countries
China
Outcome results
None listed