Risk Assessment Model for Ischemic Stroke Endpoint Events

Recruiting

Phase N/A Results N/A

Trial Description

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.

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.

Conditions

Trial 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary ischemic stroke recurrence events 1 year follow-up
Secondary death, disability, and endpoint events of atherosclerotic cardiovascular disease and atherosclerotic peripheral vascular disease 1 year follow-up

Biospecimen Retention:Samples With DNA - Biospecimen includes serum, blood clots and whole blood.

Sponsors