An observational study in Ischemic Stroke, sponsored by Tongji Hospital. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by Tongji Hospital · Observational
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.
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.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's enrollment of 1,200 is above the median of 300 across 787 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Tongji Hospital is the lead sponsor of 384 studies on the registry; 208 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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: Drug Therapy · Diagnostic Test: Routine Blood Test and Image Scan · Other: Intravascular therapy · Other: Emergency Treatment · Other: Medical history
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.
Diagnostic Test: Routine Blood Test and Image Scan · Other: Medical history
Drug page: Medication
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
Also known as: Aspirin, Clopidogrel, Statin
Routine blood test(HCY, LDL and ect.) and image scan (DWI, DSA and ect.)
Intravascular therapy including thrombectomy
Emergency treatment including time to self-diagnosis of stroke, time to call for help, devices used to hospital and ect.
Medical history including hypertension, diabetes, hyperlipemia and ect.
Modified Rankin Scale scores
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.
Time frame: Change from Baseline mRS score at 24 months
Re-admission to the hospital
Re-admission to the hospital (patients without new symptoms and admitted to the hospital simply for physical examination are not counted)
Time frame: 24 months
Cerebral and Cardio vascular diseases
Cerebral and Cardio vascular diseases including small vessel diseases, white matter ischemia, micro hemorrhage, ischemic stroke and hemorrhagic stroke.
Time frame: 24 months
Neurological deterioration-1
Neurological deterioration (NIHSS score)
Time frame: Change from Baseline NIHSS score at 24 months
Neurological deterioration-2
Neurological deterioration (FAQ score)
Time frame: Change from Baseline FAQ score at 24 months
Cognitive dysfunction
Cognitive dysfunction (MMSE score). Patients with cognitive dysfunction will be classified into mild neurocognitive disorder, major neurocognitive disorder according to DSM-5
Time frame: Change from Baseline MMSE score at 24 months
Cognitive dysfunction
Cognitive dysfunction (MoCA score). Patients with cognitive dysfunction will be classified into mild neurocognitive disorder, major neurocognitive disorder according to DSM-5
Time frame: Change from Baseline MoCA score at 24 months
Cerebrospinal Fluid (CSF) test
Cerebrospinal Fluid (CSF) test including Tau, Aβ and ect.
Time frame: 24 months
Blood test
Blood including HCY, amino acid, LDL and ect.
Time frame: 24 months
Depression
Hamilton Depression Scale
Time frame: 24 months
Severe pulmonary infection
Severe pulmonary infection
Time frame: 24 months
Plan to share: No
Ran from Mar 2018 to primary completion in Dec 2021, 45 months.
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This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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