Chinese Journal of Stroke

Highlights on Stroke Research in 2021

WANG Yongjun, XIONG Yunyun, LI Zixiao, ZHANG Yumei, YANG Xiaomeng, WANG Shang, HUO Xiaochuan, YANG Ming, XIE Xuewei, LUO Gang, CHEN Xiaolin, LI Guangshuo, WANG Liyuan, WANG Chuanying, YAN Ran, WANG Wenjie, DUAN Chunmiao, LU Zhengzhao

2022, 17(01): 1-20. DOI: 10.3969/j.issn.1673-5765.2022.01.00110.3969/j.issn.1673-5765.2022.01.001

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Current Status, Problems and Solving Strategy of Clinical Study Design in Cerebrovascular Disease

JIN Aoming, YAN Hongyi, XIANG Xianglong, PAN Yuesong

2022, 17(01): 21-24. DOI: 10.3969/j.issn.1673-5765.2022.01.002

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Clinical Research Design in Cerebrovascular Disease

PAN Yuesong

2022, 17(01): 25-25.

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Introduction of Clinical Study Design in Cerebrovascular Disease

ZHANG Runhua, PAN Yuesong, JIANG Yong, LIU Gaifen

2022, 17(01): 26-30. DOI: 10.3969/j.issn.1673-5765.2022.01.003

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The appropriate study design based on clinical questions is the basis of ensuring correct study results in clinical studies of cerebrovascular disease (CVD). The common types of CVD clinical studies includes cross-sectional study, case-control study, cohort study, clinical registry study and clinical trial. This article introduced the design principles, application situation and precautions of these common clinical studies, taking some examples of CVD studies to illustrate them, to provide a reference for selecting the right type of clinical study.

Methods and Common Pitfalls of Sample Size Estimation in Clinical Studies

PAN Yuesong, JIN Aoming, WANG Mengxing

2022, 17(01): 31-35. DOI: 10.3969/j.issn.1673-5765.2022.01.004

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Appropriate sample size estimation was an important issue in clinical research design that clinical researchers pay attention to. Study objectives, study design, data type of the primary outcome, effect of interest, variability of the outcome measurement, type I error and power of test were key issues related to estimation of sample size in clinical studies. The main pitfalls of sample size estimation in clinical research design included direct determination of sample size without calculation, incompatibility between sample size estimation method and study design and objectives, and unreasonable parameter setting, etc.

Construction and Management of Clinical Research Database

ZHU Zhikai, HUANG Xinying, JIANG Yong

2022, 17(01): 36-42. DOI: 10.3969/j.issn.1673-5765.2022.01.005

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The construction and management of standardized clinical research database can improve the quality of research data. This review focused on the common data standards/ specifications, tools for establishing database, management precedure and common problems in the construction of clinical research databases, explored the cross-database linking mechanism, and emphasized the data security and personal information protection, to provide basis and guidance for researchers to carry out clinical researches.

Application of Statistical Methods and Typical Cases Analysis in Clinical Research

ZHENG Deqiang, DUAN Mingrui, LI Xiaochun, HOU Rui, WU Lijuan, WANG Youxin

2022, 17(01): 43-50. DOI: 10.3969/j.issn.1673-5765.2022.01.006

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he c orrect u se o f s tatistical m ethods a re a ssociated w ith t he r eliability a nd scientificity of research results in clinical research. The key points and common misuses of statistical description, statistical inference, data processing and results interpretation in clinical research were summarized and analyzed through typical case analysis in this article. Misuse of t test and analysis of variance, misuse of χ 2 test and paired χ 2 test, dummy variable s etting of categorical independent variables in regression analysis, precautions for regression analysis of repeated measurement data, multiple imputation of missing data, prudent interpretation of P value and correlation analysis results were also stressed, to provide reference and basis for clinical workers to apply normative statistical methods in scientific research, and avoid the misuse of statistical methods, so as to improve the quality and level of clinical research.

Multi-modal MRI in Intracranial Extracerebral Hemorrhage

LI Linlin, ZHANG Yingkui

2022, 17(01): 51-55. DOI: 10.3969/j.issn.1673-5765.2022.01.007

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A Survey of Current Practice in Acute Ischemic Stroke Endovascular Treatment in China in 2020

HUO Xiaochuan, LI Xiaoqing, MIAO Zhongrong, Expert Committee for Neurointervention Quality Control of National Center for Healthcare Quality Management in Neurological Diseases, Endovascular Treatment Working Committee of National Action for Quality Improvement of Acute Cerebral Infarction Reperfusion Therapy

2022, 17(01): 56-65. DOI: 10.3969/j.issn.1673-5765.2022.01.008

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Objective To investigate the prevalence, distribution and characteristics of endovascular treatment (EVT) of acute ischemic stroke (AIS) patients in China in 2020.

Methods A survey on AIS-EVT was carried out by the Expert Committee for Neurointervention Quality Control of National Center for Healthcare Quality Management in Neurological Diseases, which including the number of centers capable of performing AIS-EVT (including intra-artery thrombolysis, mechanical thrombectomy, balloon angioplasty, stent angioplasty) and number of AIS-EVT surgery, to analyze the distribution characteristics of centers with high capacity for AISEVT treatment (more than 50 cases and more than 100 cases). Combined with the gross domestic product (GDP) and per capita GDP of each region in 2020, the correlation between the number of AIS-EVT, the number of AIS-EVT per 100 000 population and GDP and per capita GDP of each region were analyzed.

Results There were 862 centers and 42 183 cases receiving AIS-EVT in all in this survey. There were 275 centers capable for treating more than 50 cases per year and the number of AIS-EVT amounted to 30 855 cases, the top six provinces of which were Guangdong, Jiangsu, He'nan, Shandong, Sichuan and Zhejiang. There were 126 centers capable for treating more than 100 cases per year, and the total number of AIS-EVT reached up to 20 642 cases, the top six regions of which were Guangdong, Jiangsu, He'nan, Shandong, Zhejiang and Shanghai. The average number of thrombectomy centers per 10 million population was 6.11, and the top six provinces were Shaanxi, Xinjiang, Zhejiang, Sichuan, Beijing and Tianjin. The average number of thrombectomy per 100 000 population was 3 cases, and the top six regions were Shanghai, Beijing, Zhejiang, Jiangsu, Shaanxi and Guangdong. The AIS-EVT number in each region was positively correlated with the population of this region (r =0.870, P <0.001), and also with GDP of this region (r =0.940, P <0.001). The number of thrombectomy per 100 000 population in each region was positively correlated with per capita GDP in this region (r =0.529, P =0.002).

Conclusions In 2020, 862 centers performed AIS-EVT in China, and the cumulative number of AIS-EVT reached up to 42 183 cases, with 3 thrombectomy per 100 000 population. The proportion of thrombectomy needs to be further improved. The number of AIS-EVT was closely related to the total GDP of a region, and the status of AIS-EVT covering the population was closely related to per capita GDP, which suggested that AIS-EVT needs to be further promoted to primary hospitals and homogenized.

Safety and Efficacy of Tirofiban in the Treatment of Mild to Moderate Non-Cardiogenic Ischemic Stroke Screened by MRI

ZHANG Junliang, HUANG Shuangfeng, XU Luyao, XIANG Wei, ZHANG Manman, LIANG Zhigang

2022, 17(01): 66-72. DOI: 10.3969/j.issn.1673-5765.2022.01.009

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Objective To investigate the safety and clinical efficacy of tirofiban in the treatment of acute noncardiogenic ischemic stroke screened by MRI.

Methods This study prospectively enrolled sixty inpatients with non-cardiogenic ischemic stroke who did not receive intravenous thrombolysis and endovascular treatment and who underwent MRI scan during 6-72 hours after stroke onset in Yantai Yuhuangding Hospital Affiliated to Qingdao University from January 2020 to January 2021. The patients with massive cerebral infarction and large vessel occlusion were excluded. All the included patients were randomly assigned in a 1:1 double-blind fashion to observation and control groups. The medication regimen as follows: in observation group (n =30), intravenous tirofiban for 72 hours and overlapped with a loading dose of 100 mg aspirin and 300 mg clopidogrel in the last 4 hours, followed by 100 mg aspirin plus 75 mg clopidogrel per day for 21 days, after 21 days of dual antiplatelet treatment, the patients were administered mono-antiplatelet treatment (aspirin 100 mg or clopidogrel 75 mg per day) for the next 69 days. The control group (n =30) was not given tirofiban, and the other oral antiplatelet regimen were the same as that in observation group. The primary outcome was symptomatic intracranial hemorrhage (sICH) within 72 hours after treatment. The secondary outcome included NIHSS score at 72 hours, 14 days after treatment, and 90-day favorable prognosis. Favorable prognosis was defined as a mRS score of 0 to 2. The primary and secondary outcomes between the two groups were compared.

Results A total of 59 patients completed the trial, 30 in observation group and 29 in control group. No significant differences were found in baseline characteristics between the two groups. There was no sICH and death in both the two groups. The NIHSS scores were lower in observation group than that in control group at 72 hours [5.00 (3.75-7.00) vs . 6.00 (5.00-8.00), P =0.042] and 14 days [3.00 (2.00-5.25) vs . 4.00 (3.00-7.00), P =0.011]. The 90-day favorable prognosis rate in observation group was higher than that in control group (66.7% vs . 41.4%, P =0.045).

Conclusions Tirofiban can be a safe and effective therapy for mild and moderate acute noncardiogenic ischemic stroke, which can improve neurological function impairment and prognosis.

The Relationship between eGFR and 1-Year Mortality in Young and Middle-aged Patients with Acute Stroke in Xi’an

ZHANG Yuyu, LIU Zhongzhong, LU Qingli, WANG Jing, LIU Pei, HOU Lina, ZHANG Na, LIN Xuemei, WANG Fang, WU Songdi

2022, 17(01): 73-79. DOI: 10.3969/j.issn.1673-5765.2022.01.010

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Objective To investigate the relationship between estimated glomerular filtration rate (eGFR) and 1-year mortality in young and middle-aged patients with acute stroke in Xi’an.

Methods Based on the Xi'an Stroke Register database, the clinical and follow-up data of patients with acute stroke from four “AAA” hospitals in Xi’an from January to December 2015 were retrospectively analyzed. Young and middle-aged patients aged between 18 and 64 years were selected. All the subjects were divided into 5 groups (Q1-Q5) according to the quintile of eGFR, and the clinical characteristics and 1-year all-cause mortality among the 5 groups were compared. Multivariate Cox regression analysis was performed to analyze the relationship between eGFR and 1-year mortality in young and middle-aged patients with acute stroke. Kaplan-Meier survival curve analysis was used to analyze the survival of the 5 groups.

Results A total 1405 eligible patients were enrolled in this study, with a mean age of 53.9±8.0 years old and 961 males (68.4%). After adjustment for the related confounders, multivariate Cox regression analysis showed that 1-year mortality in young and middle-aged patients with acute stroke decreased by 8% per 5 mL/(min·1.73 m2) increase in eGFR (HR 0.92, 95%CI 0.87-0.97, P =0.002); compared with the Q5 group [eGFR <69.6 mL/(min·1.73 m2)], 1-year mortality increased by 1.40 times (HR 2.40, 95%CI 1.02-5.67, P =0.045) in Q1 group [<69.6 mL/(min·1.73 m2)], while there was no significant increase in 1-year mortality in other 3 groups. Kaplan-Meier survival analysis found a significant decrease in survival rate in the Q1 group compared to the other groups (Q1: 89.7% vs . Q2: 96.8%, Q3: 94.4%, Q4: 97.9%, Q5: 96.1%), all with statistical differences (P <0.001).

Conclusions Decreased eGFR level is an independent risk factor for 1-year mortality in young and middle-aged patients with acute stroke, and eGFR <69.6 mL/(min·1.73 m2) was associated with an obvious increase in 1-year mortality.

Predictive Value of P-Wave Indices for Atrial Fibrillation Detected after Stroke

YANG Xiaomeng, WU Yueyang, YOU Jia, JIANG Yong, HUANG Xinying, WANG Yongjun

2022, 17(01): 80-84. DOI: 10.3969/j.issn.1673-5765.2022.01.011

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Objective To investigate the relationship between P-wave indices and atrial fibrillation (AF) detected after stroke (AFDAS).

Methods This study was based on the database of ischemic stroke patients enrolled in the Third China National Stroke Registry (CNSR Ⅲ) from August 2015 to March 2018. The patients without AF history and AF diagnosis by ECG at admission were included this study. These patients were divided into two groups according to the results of ECG and 24-hour Holter monitor during the hospitalization: sinus rhythm group and AFDAS group. The baseline data including the general clinical features, disease history, imaging characteristics of lesions and echocardiography (diameter of left atrial, left ventricular ejection fraction), P-wave indices (PR interval, P-wave duration, PTFV1) between the two groups were compared. Multivariate logistic regression analysis and receiver operator characteristic curve were used to analyze the effect of P-wave indices on AFDAS.

Results A total of 12 248 patients were finally included, with a mean age of 61.7±11.1 years old and 54 cases (0.4%) with AFDAS. Multivariate analysis showed that PTFV1 increased by 1000 μV·ms (OR 1.19, 95%CI 1.06-1.35, P =0.004) and PTFV1>4000 μV·ms (OR 2.20, 95%CI 1.16- 4.15, P =0.016) was strongly associated with AFDAS. The AUC of PTFV1 increased by 1000 μV·ms in predicting AFDAS was 0.604 (95%CI 0.528-0.679).

Conclusions PTFV1 was an effective predictor for AF detected after stroke.

Brain Health Services: Organization, Structure, and Challenges for Implementation. A User Manual for BrainHealth Services (Part 1)

Translators: ZHENG Huaguang, LI Wenbo, WANG Ruiqing, WANG Yongjun

2022, 17(01): 85-92. DOI: 10.3969/j.issn.1673-5765.2022.01.012

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