Predictors and Prognostic Factors on the Acute Ischemic Stroke

Terminated

• Conditions: Ischemic Stroke
• Interventions: Drug: Drug Therapy; Diagnostic Test: Routine Blood Test and Image Scan; Other: Intravascular therapy; Other: Emergency Treatment; Other: Medical history

• Registration Number: NCT03122002
• Lead Sponsor: Tongji Hospital

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.

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-16
• Study First Posted: 2017-04-20
• Study Start: 2018-03-03
• Primary Completion: 2021-12-31
• Study Completion: 2022-09-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-03
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients With Ischemic Stroke	Medical history	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.
Healthy Control	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.
Patients With Ischemic Stroke	Drug Therapy	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.
Patients With Ischemic Stroke	Routine Blood Test and Image Scan	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.
Patients With Ischemic Stroke	Intravascular therapy	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.
Healthy Control	Routine Blood Test and Image Scan	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.
Patients With Ischemic Stroke	Emergency Treatment	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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-2	Change from Baseline FAQ score at 24 months	Neurological deterioration (FAQ score)
Cognitive dysfunction	Change from Baseline MoCA score at 24 months	Cognitive dysfunction (MoCA score). Patients with cognitive dysfunction will be classified into mild neurocognitive disorder, major neurocognitive disorder according to DSM-5
Neurological deterioration-1	Change from Baseline NIHSS score at 24 months	Neurological deterioration (NIHSS score)
Cerebrospinal Fluid (CSF) test	24 months	Cerebrospinal Fluid (CSF) test including Tau, Aβ and ect.
Severe pulmonary infection	24 months	Severe pulmonary infection
Blood test	24 months	Blood including HCY, amino acid, LDL and ect.
Depression	24 months	Hamilton Depression Scale

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China