China Registry of Non-disabling Ischemic Cerebrovascular Events

Study Overview
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Brief Summary
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The burden of non-disabling ischemic cerebrovascular events (NICE) is significantly increased. In order to achieve accurate risk stratification and effective treatments, developing new diagnostic, therapeutic, and prognostic strategies is indispensable. Chinese registry of NICE is a national multi-center prospective study aimed to explore the epidemiology, new biomarkers, risk factors and prognostic models.

Detailed Description
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The pathophysiology of transient ischemic attack (TIA) and minor stroke is a continuous progression. TIA and minor stroke exhibit the common substantial risk factors for early stroke recurrence and epidemiological characteristic. Since TIA and minor stroke may leave impermanent or mild neurological deficit, they are termed as non-disabling ischemic cerebrovascular disease (NICE). The results of the China Chronic Disease and Risk Factor Surveillance (CCDRFS) 2010 showed that the age-standardized prevalence of TIA is 2.27%. Estimated 23.9 million people may have experienced a TIA in China. The TIA knowing-rate is approximately 3.08% in Chinese adults, only 5.02% received treatment and 4.07% received guideline recommended therapy. The Second China National Stroke Registry (CNSR-II) indicated that minor stroke accounted for 42.23% of all the hospitalized patients of ischemic stroke, which is much higher than that showed in CNSR-I (2007-2008). Thus, it is imperative to develop new strategies to improve the diagnosis, risk prediction and appropriate management of NICE. NICE is an attractive researching area globally. According to the large quantities of NICE patients in China and the low standardized therapeutic rate, the awareness of NICE is largely insufficient. The purpose of the present study is to establish a multi-center national prospective database of NICE, including clinical information and biological samples library and, to further explore the epidemiology, new biomarkers, risk factors, and prognostic models.

Official Title
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China Registry of Non-disabling Ischemic Cerebrovascular Events: A Prospective Multi-center, National Registry Trail

Conditions
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Transient Ischemic Attack, Minor Stroke

Intervention / Treatment
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* Other: observational only- no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old elapsed time from last episode to registry <48 hours Exclusion Criteria: patients who refused to participate in the research, and patients who failed to complete the follow-up protocol. patients with malignant tumors, or patients with severe liver or kidney disease, whose life expectancy is less than 1 year. patients who received endovascular or thrombolytic therapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NICE patients<br>Non-disabling ischemic cerebrovascular events patients indicate patients with transient ischemic attack and minor stroke (National Institute of Health stroke scale, NIHSS≤3). | Other: observational only- no intervention<br>* observational only- no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Death from any cause | 3 months | 
| Death | Death from any cause | 6 months | 
| Death | Death from any cause | 12 months | 
| Stroke recurrence | Ischemic stroke | 3 months | 
| Stroke recurrence | Ischemic stroke | 6 months | 
| Stroke recurrence | Ischemic stroke | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorrhagic stroke | Cerebral hemorrhage and subaraclmoid hemorrhage | 3 months | 
| Hemorrhagic stroke | Cerebral hemorrhage and subaraclmoid hemorrhage | 6 months | 
| Hemorrhagic stroke | Cerebral hemorrhage and subaraclmoid hemorrhage | 12 months | 
| Cardiovascular disease | Coronary heart disease and Angina pectoris | 3 months | 
| Cardiovascular disease | Coronary heart disease and Angina pectoris | 6 months | 
| Cardiovascular disease | Coronary heart disease and Angina pectoris | 12 months | 
| Functional outcome | Modified Rankin Scale ≥3 | 3 months | 
| Functional outcome | Modified Rankin Scale ≥3 | 6 months | 
| Functional outcome | Modified Rankin Scale ≥3 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transient Ischemic Attack, minor Stroke, non-disabling ischemic cerebrovascular events, biomarker, epidemiology, prognosis