China Registry of Non-disabling Ischemic Cerebrovascular Events (CR-NICE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Transient Ischemic Attack; Minor Stroke
• Intervention / Treatment: Other: observational only- no intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 404000
      • Chongqing Three Gorges Central Hospital
  • Fujian
    • Xiamen, Fujian, China, 361003
      • The First Affiliated hospital of Xiamen University
  • Guangdong
    • Jiangmen, Guangdong, China, 529000
      • Jiangmen Central Hospital
    • Shaoguan, Guangdong, China, 512026
      • Yuebei People's Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Shijiazhuang The Third Hospital
    • Xingtai, Hebei, China, 054000
      • Xingtai Third Hospital
  • Henan
    • Anyang, Henan, China, 455000
      • Anyang People's Hospital
    • Hebi, Henan, China, 458000
      • The People's Hospital of Hebi
    • Jiaozuo, Henan, China, 454150
      • The Second People 's Hospital of Jiaozuo
    • Kaifeng, Henan, China, 475000
      • The Huaihe Hospital of Henan University
    • Luohe, Henan, China, 462000
      • Luohe Central Hospital
    • Luoyang, Henan, China, 471000
      • The First Affiliated Hospital of Henan University of Science and Technology
    • Luoyang, Henan, China, 471000
      • Luoyang Central Hospital Affiliated To Zhengzhou University
    • Nanyang, Henan, China, 473065
      • Nanshi Hospital of Nanyang
    • Nanyang, Henan, China, 473000
      • Nanyang City Central Hospital
    • Pingdingshan, Henan, China, 467000
      • The First People's Hospital of Pingdingshan
    • Puyang, Henan, China, 457000
      • People's Hospital of Puyang
    • Sanmenxia, Henan, China, 472000
      • Sanmenxia Central Hospital
    • Shangqiu, Henan, China, 476100
      • The First People's Hospital of Shangqiu
    • Xinxiang, Henan, China, 453000
      • Xinxiang Central Hospital
    • Xinxiang, Henan, China, 453000
      • The First Affiliated Hospital of Xinxiang Medical University
    • Xinyang, Henan, China, 464000
      • Xinyang Central Hospital
    • Xuchang, Henan, China, 461000
      • Xuchang Central Hospital
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450003
      • People's Hospital of Zhengzhou
    • Zhengzhou, Henan, China, 450000
      • The fifth Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450000
      • The Medical Group of Zhengzhou First People's Hospital
    • Zhoukou, Henan, China, 466000
      • Zhoukou Central Hospital
    • Zhumadian, Henan, China, 463000
      • Zhumadian Central Hospital
  • Hubei
    • Jingmen, Hubei, China, 448000
      • Jingmen No.1 People 's Hospital
    • Wuhan, Hubei, China, 430022
      • Wuhan No.1 hospital
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014010
      • The First Affiliated Hospital of Baotou Medical College
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The Second Affiliated Hospital of Nanchang University
  • Liaoning
    • Shenyang, Liaoning, China, 110840
      • The General Hospital of Shenyang Military
  • Shanxi
    • Ankang, Shanxi, China, 725000
      • Ankang HospitaL of Traditional Chinese Medicine
    • Fenyang, Shanxi, China, 032200
      • Fenyang Hospital
    • Linfen, Shanxi, China, 041000
      • Linfen People's Hospital
    • Xi'an Shi, Shanxi, China, 710068
      • Shanxi Provincial People 's Hospital
  • Sichuan
    • Luzhou, Sichuan, China, 646000
      • The Affiliated Hospital Of Southwest Medical University
    • Mianyang, Sichuan, China, 621000
      • Mianyang Central Hospital
    • Nanchong, Sichuan, China, 637000
      • Nanchong central hospital
  • Xinjiang
    • Urumqi, Xinjiang, China, 830000
      • The Institute of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region
  • Yunnan
    • Kunming, Yunnan, China, 650101
      • The Second Affiliated Hospital of Kunming Medical University
    • Kunming, Yunnan, China, 650051
      • Yan'an Affiliated Hospital to Kunming Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: observational only- no intervention; observational only- no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death from any cause	12 months
Death	Death from any cause	3 months
Death	Death from any cause	6 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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhengzhou University
• Collaborators: Beijing Tiantan Hospital; National Health and Family Planning Commission, P.R.China
• Investigators: Principal Investigator: Yuming Xu, MD, PhD, The First Affiliated Hospital of Zhengzhou University

Publications and helpful links

General Publications

• Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
• 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.
• Yaghi S, Rostanski SK, Boehme AK, Martin-Schild S, Samai A, Silver B, Blum CA, Jayaraman MV, Siket MS, Khan M, Furie KL, Elkind MS, Marshall RS, Willey JZ. Imaging Parameters and Recurrent Cerebrovascular Events in Patients With Minor Stroke or Transient Ischemic Attack. JAMA Neurol. 2016 May 1;73(5):572-8. doi: 10.1001/jamaneurol.2015.4906.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Wardlaw JM, Brazzelli M, Chappell FM, Miranda H, Shuler K, Sandercock PA, Dennis MS. ABCD2 score and secondary stroke prevention: meta-analysis and effect per 1,000 patients triaged. Neurology. 2015 Jul 28;85(4):373-80. doi: 10.1212/WNL.0000000000001780. Epub 2015 Jul 1.
• 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.
• Suri MF, Qiao Y, Ma X, Guallar E, Zhou J, Zhang Y, Liu L, Chu H, Qureshi AI, Alonso A, Folsom AR, Wasserman BA. Prevalence of Intracranial Atherosclerotic Stenosis Using High-Resolution Magnetic Resonance Angiography in the General Population: The Atherosclerosis Risk in Communities Study. Stroke. 2016 May;47(5):1187-93. doi: 10.1161/STROKEAHA.115.011292. Epub 2016 Apr 7.
• Amarenco P, Lavallee PC, Labreuche J, Albers GW, Bornstein NM, Canhao P, Caplan LR, Donnan GA, Ferro JM, Hennerici MG, Molina C, Rothwell PM, Sissani L, Skoloudik D, Steg PG, Touboul PJ, Uchiyama S, Vicaut E, Wong LK; TIAregistry.org Investigators. One-Year Risk of Stroke after Transient Ischemic Attack or Minor Stroke. N Engl J Med. 2016 Apr 21;374(16):1533-42. doi: 10.1056/NEJMoa1412981.
• Wang Y, Pan Y, Zhao X, Li H, Wang D, Johnston SC, Liu L, Meng X, Wang A, Wang C, Wang Y; CHANCE Investigators. Clopidogrel With Aspirin in Acute Minor Stroke or Transient Ischemic Attack (CHANCE) Trial: One-Year Outcomes. Circulation. 2015 Jul 7;132(1):40-6. doi: 10.1161/CIRCULATIONAHA.114.014791. Epub 2015 May 8.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2017
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: biomarker; prognosis; epidemiology; transient Ischemic Attack; minor Stroke; non-disabling ischemic cerebrovascular events
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: GN-2016R0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No