Clinical trial NCT03079674: China Registry of Non-disabling Ischemic Cerebrovascular Events
Official title: China Registry of Non-disabling Ischemic Cerebrovascular Events: A Prospective Multi-center, National Registry Trail
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transient Ischemic Attack
Minor Stroke
Keywords: transient Ischemic Attack
minor Stroke
non-disabling ischemic cerebrovascular events
biomarker
epidemiology
prognosis
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: National Health and Family Planning Commission, P.R.China
name: Beijing Tiantan Hospital
First posted: 2017-03-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients (≥18 years) within 48 hours of onset of a minor stroke (National Institute of Health stroke scale, NIHSS≥3) and TIA.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years old
2. elapsed time from last episode to registry \<48 hours

Exclusion Criteria:

1. patients who refused to participate in the research, and patients who failed to complete the follow-up protocol.
2. patients with malignant tumors, or patients with severe liver or kidney disease, whose life expectancy is less than 1 year.
3. patients who received endovascular or thrombolytic therapy.

Primary outcomes:
measure: Death
timeFrame: 3 months
measure: Death
timeFrame: 6 months
measure: Death
timeFrame: 12 months
measure: Stroke recurrence
timeFrame: 3 months
measure: Stroke recurrence
timeFrame: 6 months
measure: Stroke recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Hemorrhagic stroke
timeFrame: 3 months
measure: Hemorrhagic stroke
timeFrame: 6 months
measure: Hemorrhagic stroke
timeFrame: 12 months
measure: Cardiovascular disease
timeFrame: 3 months
measure: Cardiovascular disease
timeFrame: 6 months
measure: Cardiovascular disease
timeFrame: 12 months
measure: Functional outcome
timeFrame: 3 months
measure: Functional outcome
timeFrame: 6 months
measure: Functional outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Three Gorges Central Hospital
state: Chongqing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Shaoguan
country: China
facility: Yuebei People's Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: Shijiazhuang the Third Hospital
state: Hebei
city: Xingtai
country: China
facility: Xingtai Third Hospital
state: Hebei
city: Anyang
country: China
facility: Anyang People's Hospital
state: Henan
city: Hebi
country: China
facility: The People's Hospital of Hebi
state: Henan
city: Jiaozuo
country: China
facility: The Second People 's Hospital of Jiaozuo
state: Henan
city: Kaifeng
country: China
facility: The Huaihe Hospital of Henan University
state: Henan
city: Luohe
country: China
facility: Luohe Central Hospital
state: Henan
city: Luoyang
country: China
facility: Luoyang Central Hospital Affiliated to Zhengzhou University
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Nanyang
country: China
facility: Nanyang City Central Hospital
state: Henan
city: Nanyang
country: China
facility: Nanshi Hospital of Nanyang
state: Henan
city: Pingdingshan
country: China
facility: The First People's Hospital of Pingdingshan
state: Henan
city: Puyang
country: China
facility: People's Hospital of Puyang
state: Henan
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital
state: Henan
city: Shangqiu
country: China
facility: The First People's Hospital of Shangqiu
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
state: Henan
city: Xinyang
country: China
facility: Xinyang Central Hospital
state: Henan
city: Xuchang
country: China
facility: Xuchang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Fifth Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: The Medical Group of Zhengzhou First People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: People's Hospital of Zhengzhou
state: Henan
city: Zhoukou
country: China
facility: Zhoukou Central Hospital
state: Henan
city: Zhumadian
country: China
facility: Zhumadian Central Hospital
state: Henan
city: Jingmen
country: China
facility: Jingmen No.1 People 's Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan NO.1 Hospital
state: Hubei
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College
state: Inner Mongolia
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military
state: Liaoning
city: Ankang
country: China
facility: Ankang HospitaL of Traditional Chinese Medicine
state: Shanxi
city: Fenyang
country: China
facility: Fenyang Hospital
state: Shanxi
city: Linfen
country: China
facility: Linfen People's Hospital
state: Shanxi
city: Xi'an Shi
country: China
facility: Shanxi Provincial People 's Hospital
state: Shanxi
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Mianyang
country: China
facility: Mianyang Central Hospital
state: Sichuan
city: Nanchong
country: China
facility: Nanchong Central Hospital
state: Sichuan
city: Urumqi
country: China
facility: The Institute of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region
state: Xinjiang
city: Kunming
country: China
facility: Yan'an Affiliated Hospital to Kunming Medical University
state: Yunnan
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Yuming Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Yilong Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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