Clinical trial NCT03122002: Predictors and Prognostic Factors on the Acute Ischemic Stroke
Official title: A Prospective Cohort Study of Predictors and Prognostic Factors on the Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke
Cerebral Infarction
Cerebrovascular Disorders
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Rankin Scale scores
timeFrame: Change from Baseline mRS score at 24 months
Secondary outcomes:
measure: Re-admission to the hospital
timeFrame: 24 months
measure: Cerebral and Cardio vascular diseases
timeFrame: 24 months
measure: Neurological deterioration-1
timeFrame: Change from Baseline NIHSS score at 24 months
measure: Neurological deterioration-2
timeFrame: Change from Baseline FAQ score at 24 months
measure: Cognitive dysfunction
timeFrame: Change from Baseline MMSE score at 24 months
measure: Cognitive dysfunction
timeFrame: Change from Baseline MoCA score at 24 months
measure: Cerebrospinal Fluid (CSF) test
timeFrame: 24 months
measure: Blood test
timeFrame: 24 months
measure: Depression
timeFrame: 24 months
measure: Severe pulmonary infection
timeFrame: 24 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wei Wang, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shang K, Chen X, Cheng C, Luo X, Xu S, Wang W, Liu C. Arterial Tortuosity and Its Correlation with White Matter Hyperintensities in Acute Ischemic Stroke. Neural Plast. 2022 Mar 24;2022:4280410. doi: 10.1155/2022/4280410. eCollection 2022.
citation: Qin C, Zhao XL, Ma XT, Zhou LQ, Wu LJ, Shang K, Wang W, Tian DS. Proteomic profiling of plasma biomarkers in acute ischemic stroke due to large vessel occlusion. J Transl Med. 2019 Jul 1;17(1):214. doi: 10.1186/s12967-019-1962-8.