Predictors and Prognostic Factors on the Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

A Prospective Cohort Study of Predictors and Prognostic Factors on the Acute Ischemic Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03122002
• Other study ID #: Know more about AIS
• Status: Terminated
• Start date: March 3, 2018
• Est. completion date: September 1, 2022

Study information

• Verified date: December 2022
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1200
• Est. completion date: September 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• 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

Diagnostic Test:
• Routine Blood Test and Image Scan
Routine blood test(HCY, LDL and ect.) and image scan (DWI, DSA and ect.)

Other:
• Intravascular therapy
Intravascular therapy including thrombectomy
• Emergency Treatment
Emergency treatment including time to self-diagnosis of stroke, time to call for help, devices used to hospital and ect.
• Medical history
Medical history including hypertension, diabetes, hyperlipemia and ect.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline mRS score at 24 months
Secondary	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)	24 months
Secondary	Cerebral and Cardio vascular diseases	Cerebral and Cardio vascular diseases including small vessel diseases, white matter ischemia, micro hemorrhage, ischemic stroke and hemorrhagic stroke.	24 months
Secondary	Neurological deterioration-1	Neurological deterioration (NIHSS score)	Change from Baseline NIHSS score at 24 months
Secondary	Neurological deterioration-2	Neurological deterioration (FAQ score)	Change from Baseline FAQ score at 24 months
Secondary	Cognitive dysfunction	Cognitive dysfunction (MMSE score). Patients with cognitive dysfunction will be classified into mild neurocognitive disorder, major neurocognitive disorder according to DSM-5	Change from Baseline MMSE score at 24 months
Secondary	Cognitive dysfunction	Cognitive dysfunction (MoCA score). Patients with cognitive dysfunction will be classified into mild neurocognitive disorder, major neurocognitive disorder according to DSM-5	Change from Baseline MoCA score at 24 months
Secondary	Cerebrospinal Fluid (CSF) test	Cerebrospinal Fluid (CSF) test including Tau, Aß and ect.	24 months
Secondary	Blood test	Blood including HCY, amino acid, LDL and ect.	24 months
Secondary	Depression	Hamilton Depression Scale	24 months
Secondary	Severe pulmonary infection	Severe pulmonary infection	24 months