Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis
Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis
This is a single-center prospective cohort study of predictive factors related to prognosis
 of ischemic stroke due to large-artery atherosclerosis.

 From March 1, 2021 to December 31, 2026, 1000 patients with ischemic stroke due to
 large-artery atherosclerosis who are admitted to the Department of Neurology or Neurosurgery,
 Tongji Hospital are going to be recruited. Detailed clinical data in emergency room and
 in-hospital will be obtained from the medical record reviews, and the National Institutes of
 Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) score will be done by certified
 neurologists to assess the severity of the disease in acute stage and treatment outcome
 during the follow-up. All cases will undergo routine blood tests, brain magnetic resonance
 imaging (MRI) and cerebral vascular examination, such as TCD, CTA, HRMR or DSA. The
 investigators will analyze the in-hospital factors that could predict the outcome to provide
 more evidence-based suggestions in the treatment and prognosis of atherosclerotic ischemic
 cerebrovascular disease.
The detaited information about this trial is described below

 1. Quality assurance: The research proposal is reviewed by an Independent Research Panel.
 If the proposal is approved, access to the study data is provided in a secure data
 sharing environment after receipt of a signed Data Sharing Agreement.

 2. Data check: Researchers must submit a proposal to conduct a scientifically relevant
 analysis of the study data.

 3. Source data verification: Medical records, electronic case report forms, and imaging
 would be processed by certified neurologists.

 4. Data included:

 4.1 Baseline Variables: NIHSS and mRS scores before ischemic stroke 4.2 In-hospital
 Variables: 4.2.1 Main symptoms（1=facial paralysis 2=limb weakness 3=limb numbness
 4=facial numbness 5=lalopathy 6=ataxia 7=dysphagia 8=bulbar paralysis 9=dizziness
 10=nausea and vomit 11=vision disorder 12=confusion 13=headache 14=unconsciousness
 15=others） NIHSS and mRS scores after admission 4.2.2 Brain CT and ASPECT scores 4.2.3
 DWI 4.2.4 CTA, MRA, DSA, carotid artery ultrasound andTCD to evaluate the stenosis
 degree of large vessels 4.2.5 HRMR to evaluate the changes of the plaque of intracranial
 stenosis 4.2.6 Blood routine tests 4.2.7 HbALc and FBG 4.2.8 LDL HDL ApoA1 and ApoB
 4.2.9 Cardiac TnI and NT-proBNP 4.2.10 Proteomic analysis of fresh plasma 4.2.11
 Histopathological tissues and transcriptomics of CEA

 5. Standard Operating Procedures 5.1 Patient recruitment: From March 1, 2021 to December
 31, 2026, 1000 patients with ischemic stroke due to large-artery atherosclerosis who are
 admitted to the Department of Neurology and Neurosurgery, Tongji Hospital are going to
 be recruited 5.2 Data collection: Detailed clinical data in emergency room and
 in-hospital will be obtained from the medical record reviews, and the National
 Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) score will be
 done by certified neurologists to assess the severity of the disease in acute stage and
 clinical outcome during the follow-up. All cases would undergo routine blood tests,
 brain magnetic resonance imaging (MRI) and cerebral vascular examination, such as TCD,
 CTA, HRMR or DSA.

 5.3 Data management, The research data is reviewed by an Independent Research Panel.

 5.4 Data analysis: Biostatisticians from the Department of Neurology, Tongji Hospital,
 Tongji Medical College of Huazhong University of Science and Technology will conduct
 statistical analysis

 6. Sample size assessment: About 1000 cases.

 7. Plan for missing data: The number of lost cases will be treated as the deleted value and
 the lost rate will be indicated. Complete sample intentionality analysis and
 intent-to-treat (ITT) analysis would be performed on the end points. During the
 analysis, if there is a statistical difference in the results, the number of
 participants lost in the exposed group will be deleted, and the number of participants
 lost to in the non-exposed group will be added. If there is still a statistical
 difference in the results, the loss of follow-up will not have an impact on the analysis
 results of this group.

 8. Statistical analysis: All statistical data would be analyzed by the SPSS Software 24.0
 version. Continuous variables would be reported as median (range, minimum-maximum),
 which would be compared by Mann-Whitney test, and categorical data would be represented
 as percentages and frequencies, which would be compared by the two-tailed Fisher's exact
 test or one-way ANOVA. P<0.05 would be considered statistically significant.
Inclusion Criteria:

 -  Ischemic stroke due to large-artery atherosclerosis has been proved by clinical
 symptoms and imaging examinations.

 -  Symptomatic superior arch stenosis >50%

 -  Asymptomatic superior arch stenosis was >70%

 -  written informed consent was obtained from patients or their surrogates before
 enrollment.

 Exclusion Criteria:

 -  Brain CT or MRI showing cerebral hemorrhage (excluded ischemic stroke with hemorrhage
 transformation)

 -  With severe systemic disease, are expected to survive < 3 months

 -  Patients will not able to provide continuous follow-up information