Risk Assessment Model for Ischemic Stroke Endpoint Events
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Observational [Patient Registry]

Summary: 
      The present study aims to develope a risk assessment model of ischemic stroke endpoint events
      combining multi-dimensional traditional Chinese medicine(TCM) indicators with modern medicine
      indicators. The proposed study is a registry study based participant survey conducted in 7
      hospitals nationwide in China. After obtaining informed consent, a total of 3000 study
      patients diagnosed with ischemic stroke will be recruited. 1-year follow-ups are carried out
      on-site in hospitals and by telephone to track endpoint events. At the same time, we
      conducted a prospective, multicenter, real-world longitudinal cohort study at 7 hospitals in
      China to investigate the clinical effectiveness of Qilong capsule (QLC) combined with CT for
      IS with Qi deficiency and blood stasis syndrome.
    

Detailed description: 
      Stroke is characterized by high incidence and high rates of recurrence and other endpoint
      events. Risk assessment is important for secondary prevention of ischemic stroke. To date, no
      study has been conducted to evaluate the risk of ischemic stroke endpoint events by
      establishing risk accessment models combining TCM and modern medicine indicators.

      The present study aims to develope a risk assessment model of ischemic stroke endpoint events
      combining multi-dimensional TCM indicators with modern medicine indicators. The proposed
      study is a registry study based participant survey conducted in 7 hospitals nationwide in
      China. After obtaining informed consent, a total of 3000 study patients diagnosed with
      ischemic stroke will be recruited. 1-year follow-ups are carried out on-site in hospitals and
      by telephone to track endpoint events. Comparative analysis of prevalence of endpoint events
      and other TCM or modern medicine features in different groups is conducted using frequency
      analysis and chi-squared tests, and expressed with composition ratios. Comparative analysis
      of quantitative scores of the scales and related syndromes or symptoms is conducted using
      rank-sum test. Correlation analysis of endpoint events and TCM or modern medicine factors
      will be performed using multivariate Cox proportional hazard model.

      Participants in the exposed group were treated with QLC, and those in the non-exposed group
      were not treated with QLC. All participants in two groups received standard treatment without
      restriction. The intervention course of QLC was 12 weeks. All participants returned for
      in-person follow-up visits at the 12th week and 24th week. Primary outcome measures included
      a modified Rankin Scale (mRS), the National Institute of Health Stroke Scale (NIHSS), and the
      Barthel Index (BI). Secondary outcome measures included TCM syndromes (Qi deficiency syndrome
      score, blood stasis syndrome score), psychological index (self-rating depression scale, SDS;
      self-rating anxiety scale, SAS), blood lipid index, blood coagulation index, and
      homocysteine. Multiple imputations were used for any missing data. Propensity score matching
      (PSM) was used to deal with any confounding factors (age, gender, scale score, etc.). Rank
      alignment transformation variance analysis (ART ANOVA) and generalized linear mixed model
      (GLMM) were introduced to improve the scientific and accuracy of repeated measurement data.
      All statistical calculations were carried out with R 3.6.1 statistical analysis software.
    

Intervention name(s): Qilong capsules (QLC), produced by Jining Huaneng Pharmaceutical Factory Co., Ltd.
Intervention type(s): Drug
Intervention description(s): The recommended dosage of QLC was 0.4g each time, 3 times a day. The course of treatment was 12 weeks.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be comprised of those who meet all inclusion criteria and no
        exclusion or elimination criteria. Study personnel will continuously screen eligible
        patients presenting to the hospitals until the sample size of 3000 is reached. This study
        will be conducted in 7 hopitals nationwide in China, including Dongzhimen Hospital
        affiliated to Beijing University of Chinese Medicine, Beijing Tian Tan Hospital affiliated
        to Capital Medical University, Guangdong Provincial Hospital of TCM, Affiliated Hospital of
        Changchun University of Chinese Medicine, the first Hospital Affiliated to Henan University
        of TCM, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, and Taiyuan
        Municipal Hospital of TCM.
      
Biospecimen description: 
      Biospecimen includes serum, blood clots and whole blood.
    
Keywords: Ischemic Stroke; Secondary Prevention; Endpoint Events; Risk Assessment; Traditional Chinese Medicine; Registry Study; Clinical effectiveness; Cohort study