China Registry of Non-disabling Ischemic Cerebrovascular Events

NCT ID: NCT03079674

Last Updated: 2017-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2020-02-01

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.

Conditions

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Transient Ischemic Attack Minor Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NICE patients

Non-disabling ischemic cerebrovascular events patients indicate patients with transient ischemic attack and minor stroke (National Institute of Health stroke scale, NIHSS≤3).

observational only- no intervention

Intervention Type OTHER

observational only- no intervention

Interventions

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observational only- no intervention

observational only- no intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health and Family Planning Commission, P.R.China

OTHER_GOV

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

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Yuming-Xu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuming Xu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Yilong Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Chongqing Three Gorges Central Hospital

Chongqing, Chongqing Municipality, China

Site Status

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Site Status

Yuebei People's Hospital

Shaoguan, Guangdong, China

Site Status

Shijiazhuang the Third Hospital

Shijiazhuang, Hebei, China

Site Status

Xingtai Third Hospital

Xingtai, Hebei, China

Site Status

Anyang People's Hospital

Anyang, Henan, China

Site Status

The People's Hospital of Hebi

Hebi, Henan, China

Site Status

The Second People 's Hospital of Jiaozuo

Jiaozuo, Henan, China

Site Status

The Huaihe Hospital of Henan University

Kaifeng, Henan, China

Site Status

Luohe Central Hospital

Luohe, Henan, China

Site Status

Luoyang Central Hospital Affiliated to Zhengzhou University

Luoyang, Henan, China

Site Status

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Site Status

Nanyang City Central Hospital

Nanyang, Henan, China

Site Status

Nanshi Hospital of Nanyang

Nanyang, Henan, China

Site Status

The First People's Hospital of Pingdingshan

Pingdingshan, Henan, China

Site Status

People's Hospital of Puyang

Puyang, Henan, China

Site Status

Sanmenxia Central Hospital

Sanmenxia, Henan, China

Site Status

The First People's Hospital of Shangqiu

Shangqiu, Henan, China

Site Status

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Site Status

Xinxiang Central Hospital

Xinxiang, Henan, China

Site Status

Xinyang Central Hospital

Xinyang, Henan, China

Site Status

Xuchang Central Hospital

Xuchang, Henan, China

Site Status

The Fifth Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

The Medical Group of Zhengzhou First People's Hospital

Zhengzhou, Henan, China

Site Status

People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Site Status

Zhoukou Central Hospital

Zhoukou, Henan, China

Site Status

Zhumadian Central Hospital

Zhumadian, Henan, China

Site Status

Jingmen No.1 People 's Hospital

Jingmen, Hubei, China

Site Status

Wuhan NO.1 Hospital

Wuhan, Hubei, China

Site Status

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, China

Site Status

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

The General Hospital of Shenyang Military

Shenyang, Liaoning, China

Site Status

Ankang HospitaL of Traditional Chinese Medicine

Ankang, Shanxi, China

Site Status

Fenyang Hospital

Fenyang, Shanxi, China

Site Status

Linfen People's Hospital

Linfen, Shanxi, China

Site Status

Shanxi Provincial People 's Hospital

Xi'an Shi, Shanxi, China

Site Status

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Site Status

Mianyang Central Hospital

Mianyang, Sichuan, China

Site Status

Nanchong Central Hospital

Nanchong, Sichuan, China

Site Status

The Institute of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

Site Status

Yan'an Affiliated Hospital to Kunming Medical University

Kunming, Yunnan, China

Site Status

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status

Countries

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China

Central Contacts

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Yuming Xu, MD, PhD

Role: CONTACT

86-13903711125

Yilong Wang, MD, PhD

Role: CONTACT

+86-010-67098350

Facility Contacts

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Shengli Chen, MD

Role: primary

13896226960

Jianpeng Li, PhD

Role: primary

13860192261

Jianxin Zhong, MD

Role: primary

13828071969

Suipian Lai, MD

Role: backup

13702583308

Junbin Chen, MD

Role: primary

13500205898

Yunshu Zhang

Role: primary

13323115965

Yongmei Kong, MD

Role: primary

13603193670

Qingcheng Yang, MD

Role: primary

13503728378

Lizhong Li, MD

Role: primary

13903922778

Xiangdong Xie, MD

Role: primary

13839196919

Na Chang, MD

Role: primary

18738989685

Ganqin Du, MD

Role: primary

13613882922

Baochao Zhang, MD

Role: primary

18538953366

Xinchen Zhu, MD

Role: primary

13838789875

Wenjun Xue, MD

Role: primary

13393796518

Shunqing Zhang, MD

Role: primary

13619866163

Shufang Yao, MD

Role: primary

15138163911

Yan Fang, MD

Role: primary

13937050388

Ping Zhang, MD

Role: primary

13673732099

Cheng Miao, MD

Role: primary

18339502871

Jianjun Chang, MD

Role: primary

13503761500

Shude You, MD

Role: primary

13903990688

Yuanhong He, MD

Role: primary

13837135369

Yuming Xu, MD, PhD

Role: primary

13903711125

Xiaoman Zhang, MD

Role: primary

13838566918

Daopei Zhang, MD

Role: primary

13903869251

Lei Xia, MD

Role: primary

18639493636

Ligong Gao, MD

Role: primary

13703961919

Baohua Wang, MD

Role: primary

13581328208

Guohua Chen, MD, PhD

Role: primary

13971318512

Chunyang Zhang, MD

Role: primary

18047211234

Xiaoping Yin, PhD

Role: primary

13870218146

Huisheng Chen, MD, PhD

Role: primary

13352452086

Pingkang Pan

Role: primary

13992501998

Xueying Guo, MD

Role: primary

13103581689

Chunping Chen, MD

Role: primary

15034329988

Qian Yang, MD

Role: primary

13379213866

Hua Luo, MD

Role: primary

13018154867

Jinfeng Duan, MD

Role: primary

13908116541

Yun Zhang, MD

Role: backup

13890167700

Yifei Ji

Role: primary

18909074105

Xinling Meng, MD

Role: primary

13999820954

Liping Zhan, MD

Role: primary

13668713827

Yuhong Zhu, MD

Role: primary

13708807578

References

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Meng X, Wang Y, Liu L, Pu Y, Zhao X, Wang C, Wang Y. Validation of the ABCD(2)-I score to predict stroke risk after transient ischemic attack. Neurol Res. 2011 Jun;33(5):482-6. doi: 10.1179/016164111X13007856084043.

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Giles MF, Rothwell PM. Risk of stroke early after transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. 2007 Dec;6(12):1063-72. doi: 10.1016/S1474-4422(07)70274-0. Epub 2007 Nov 13.

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Wu CM, McLaughlin K, Lorenzetti DL, Hill MD, Manns BJ, Ghali WA. Early risk of stroke after transient ischemic attack: a systematic review and meta-analysis. Arch Intern Med. 2007 Dec 10;167(22):2417-22. doi: 10.1001/archinte.167.22.2417.

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Wang Y, Zhao X, Jiang Y, Li H, Wang L, Johnston SC, Liu L, Wong KS, Wang C, Pan Y, Jing J, Xu J, Meng X, Zhang M, Li Y, Zhou Y, Zhao W, Wang Y. Prevalence, knowledge, and treatment of transient ischemic attacks in China. Neurology. 2015 Jun 9;84(23):2354-61. doi: 10.1212/WNL.0000000000001665. Epub 2015 May 8.

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Wang Y, Cui L, Ji X, Dong Q, Zeng J, Wang Y, Zhou Y, Zhao X, Wang C, Liu L, Nguyen-Huynh MN, Claiborne Johnston S, Wong L, Li H; China National Stroke Registry Investigators. The China National Stroke Registry for patients with acute cerebrovascular events: design, rationale, and baseline patient characteristics. Int J Stroke. 2011 Aug;6(4):355-61. doi: 10.1111/j.1747-4949.2011.00584.x. Epub 2011 Feb 17.

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Wang Y, Li Z, Xian Y, Zhao X, Li H, Shen H, Wang C, Liu L, Wang C, Pan Y, Wang D, Prvu Bettger J, Fonarow GC, Schwamm LH, Smith SC Jr, Peterson ED, Wang Y; GOLDEN BRIDGE-AIS investigators. Rationale and design of a cluster-randomized multifaceted intervention trial to improve stroke care quality in China: The GOLDEN BRIDGE-Acute Ischemic Stroke. Am Heart J. 2015 Jun;169(6):767-774.e2. doi: 10.1016/j.ahj.2015.03.008. Epub 2015 Mar 26.

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Song B, Fang H, Zhao L, Gao Y, Tan S, Lu J, Sun S, Chandra A, Wang R, Xu Y. Validation of the ABCD3-I score to predict stroke risk after transient ischemic attack. Stroke. 2013 May;44(5):1244-8. doi: 10.1161/STROKEAHA.113.000969. Epub 2013 Mar 26.

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Wang Y, Zhao X, Liu L, Soo YO, Pu Y, Pan Y, Wang Y, Zou X, Leung TW, Cai Y, Bai Q, Wu Y, Wang C, Pan X, Luo B, Wong KS; CICAS Study Group. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China: the Chinese Intracranial Atherosclerosis (CICAS) Study. Stroke. 2014 Mar;45(3):663-9. doi: 10.1161/STROKEAHA.113.003508. Epub 2014 Jan 30.

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Reference Type BACKGROUND
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Other Identifiers

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GN-2016R0009

Identifier Type: -

Identifier Source: org_study_id

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