CR-NICE: China Registry of Non-disabling Ischemic Cerebrovascular Events

• Sponsor: The First Affiliated Hospital of Zhengzhou University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03079674
• Collaborator: National Health and Family Planning Commission, P.R.China (Other), Beijing Tiantan Hospital (Other)
• Enrollment: 10,000
• Locations: 44
• Anticipated Duration (Months): 32
• Patients Per Site: 227.3
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transient Ischemic Attack; Minor Stroke	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 10000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: China Registry of Non-disabling Ischemic Cerebrovascular Events: A Prospective Multi-center, National Registry Trail
• Anticipated Study Start Date: Jun 1, 2017
• Anticipated Primary Completion Date: Feb 1, 2019
• Anticipated Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Death [3 months]

   Death from any cause

2. Death [6 months]

   Death from any cause

3. Death [12 months]

   Death from any cause

4. Stroke recurrence [3 months]

   Ischemic stroke

5. Stroke recurrence [6 months]

   Ischemic stroke

6. Stroke recurrence [12 months]

   Ischemic stroke

Secondary Outcome Measures

1. Hemorrhagic stroke [3 months]

   Cerebral hemorrhage and subaraclmoid hemorrhage

2. Hemorrhagic stroke [6 months]

   Cerebral hemorrhage and subaraclmoid hemorrhage

3. Hemorrhagic stroke [12 months]

   Cerebral hemorrhage and subaraclmoid hemorrhage

4. Cardiovascular disease [3 months]

   Coronary heart disease and Angina pectoris

5. Cardiovascular disease [6 months]

   Coronary heart disease and Angina pectoris

6. Cardiovascular disease [12 months]

   Coronary heart disease and Angina pectoris

7. Functional outcome [3 months]

   Modified Rankin Scale ≥3

8. Functional outcome [6 months]

   Modified Rankin Scale ≥3

9. Functional outcome [12 months]

   Modified Rankin Scale ≥3

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chongqing Three Gorges Central Hospital	Chongqing	Chongqing	China	404000
2	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	China	361003
3	Jiangmen Central Hospital	Jiangmen	Guangdong	China	529000
4	Yuebei People's Hospital	Shaoguan	Guangdong	China	512026
5	Shijiazhuang the Third Hospital	Shijiazhuang	Hebei	China	050011
6	Xingtai Third Hospital	Xingtai	Hebei	China	054000
7	Anyang People's Hospital	Anyang	Henan	China	455000
8	The People's Hospital of Hebi	Hebi	Henan	China	458000
9	The Second People 's Hospital of Jiaozuo	Jiaozuo	Henan	China	454150
10	The Huaihe Hospital of Henan University	Kaifeng	Henan	China	475000
11	Luohe Central Hospital	Luohe	Henan	China	462000
12	Luoyang Central Hospital Affiliated to Zhengzhou University	Luoyang	Henan	China	471000
13	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan	China	471000
14	Nanyang City Central Hospital	Nanyang	Henan	China	473000
15	Nanshi Hospital of Nanyang	Nanyang	Henan	China	473065
16	The First People's Hospital of Pingdingshan	Pingdingshan	Henan	China	467000
17	People's Hospital of Puyang	Puyang	Henan	China	457000
18	Sanmenxia Central Hospital	Sanmenxia	Henan	China	472000
19	The First People's Hospital of Shangqiu	Shangqiu	Henan	China	476100
20	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan	China	453000
21	Xinxiang Central Hospital	Xinxiang	Henan	China	453000
22	Xinyang Central Hospital	Xinyang	Henan	China	464000
23	Xuchang Central Hospital	Xuchang	Henan	China	461000
24	The Fifth Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450000
25	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450000
26	The Medical Group of Zhengzhou First People's Hospital	Zhengzhou	Henan	China	450000
27	People's Hospital of Zhengzhou	Zhengzhou	Henan	China	450003
28	Zhoukou Central Hospital	Zhoukou	Henan	China	466000
29	Zhumadian Central Hospital	Zhumadian	Henan	China	463000
30	Jingmen No.1 People 's Hospital	Jingmen	Hubei	China	448000
31	Wuhan NO.1 Hospital	Wuhan	Hubei	China	430022
32	The First Affiliated Hospital of Baotou Medical College	Baotou	Inner Mongolia	China	014010
33	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330006
34	The General Hospital of Shenyang Military	Shenyang	Liaoning	China	110840
35	Ankang HospitaL of Traditional Chinese Medicine	Ankang	Shanxi	China	725000
36	Fenyang Hospital	Fenyang	Shanxi	China	032200
37	Linfen People's Hospital	Linfen	Shanxi	China	041000
38	Shanxi Provincial People 's Hospital	Xi'an Shi	Shanxi	China	710068
39	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan	China	646000
40	Mianyang Central Hospital	Mianyang	Sichuan	China	621000
41	Nanchong Central Hospital	Nanchong	Sichuan	China	637000
42	The Institute of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang	China	830000
43	Yan'an Affiliated Hospital to Kunming Medical University	Kunming	Yunnan	China	650051
44	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan	China	650101

Sponsors and Collaborators

• The First Affiliated Hospital of Zhengzhou University
• National Health and Family Planning Commission, P.R.China
• Beijing Tiantan Hospital

Investigators

• Principal Investigator: Yuming Xu, MD, PhD, The First Affiliated Hospital of Zhengzhou University
• Principal Investigator: Yilong Wang, MD, PhD, Beijing Tiantan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Amarenco P, Lavallée PC, Labreuche J, Albers GW, Bornstein NM, Canhão P, Caplan LR, Donnan GA, Ferro JM, Hennerici MG, Molina C, Rothwell PM, Sissani L, Školoudík D, Steg PG, Touboul PJ, Uchiyama S, Vicaut É, 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.
• 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. Epub 2007 Nov 13. Review.
• Meng X, Wang Y, Liu L, Pu Y, Zhao X, Wang C, Wang Y. Validation of the ABCD²-I score to predict stroke risk after transient ischemic attack. Neurol Res. 2011 Jun;33(5):482-6. doi: 10.1179/016164111X13007856084043.
• 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.
• 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.
• 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.
• 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, 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, 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.
• 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. Review.
• 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. Review.
• 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.

• Responsible Party: Yuming-Xu, Principal Investigator, The First Affiliated Hospital of Zhengzhou University
• ClinicalTrials.gov Identifier: NCT03079674
• Other Study ID Numbers: GN-2016R0009
• First Posted: Mar 14, 2017
• Last Update Posted: May 11, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yuming-Xu, Principal Investigator, The First Affiliated Hospital of Zhengzhou University: transient Ischemic Attack; minor Stroke; non-disabling ischemic cerebrovascular events; biomarker; epidemiology; prognosis
• Additional relevant MeSH terms: Ischemic Attack, Transient; Ischemia

Study Results

No Results Posted as of May 11, 2017