China Registry of Non-disabling Ischemic Cerebrovascular Events

Transient Ischemic Attack Clinical Trial

— CR-NICE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03079674
• Other study ID #: GN-2016R0009
• Status: Not yet recruiting
• Phase: N/A
• First received: March 9, 2017
• Last updated: May 9, 2017
• Start date: June 1, 2017
• Est. completion date: February 1, 2020

Study information

• Verified date: May 2017
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Yuming Xu, MD, PhD
• Phone: 86-13903711125
• Email: xuyuming[@]zzu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Minor Stroke
• Transient Ischemic Attack

Intervention

Other:
• observational only- no intervention
observational only- no intervention

Locations

Country	Name	City	State
China	Ankang HospitaL of Traditional Chinese Medicine	Ankang	Shanxi
China	Anyang People's Hospital	Anyang	Henan
China	The First Affiliated Hospital of Baotou Medical College	Baotou	Inner Mongolia
China	Chongqing Three Gorges Central Hospital	Chongqing	Chongqing
China	Fenyang Hospital	Fenyang	Shanxi
China	The People's Hospital of Hebi	Hebi	Henan
China	Jiangmen Central Hospital	Jiangmen	Guangdong
China	The Second People 's Hospital of Jiaozuo	Jiaozuo	Henan
China	Jingmen No.1 People 's Hospital	Jingmen	Hubei
China	The Huaihe Hospital of Henan University	Kaifeng	Henan
China	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Yan'an Affiliated Hospital to Kunming Medical University	Kunming	Yunnan
China	Linfen People's Hospital	Linfen	Shanxi
China	Luohe Central Hospital	Luohe	Henan
China	Luoyang Central Hospital Affiliated to Zhengzhou University	Luoyang	Henan
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	Mianyang Central Hospital	Mianyang	Sichuan
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanchong Central Hospital	Nanchong	Sichuan
China	Nanshi Hospital of Nanyang	Nanyang	Henan
China	Nanyang City Central Hospital	Nanyang	Henan
China	The First People's Hospital of Pingdingshan	Pingdingshan	Henan
China	People's Hospital of Puyang	Puyang	Henan
China	Sanmenxia Central Hospital	Sanmenxia	Henan
China	The First People's Hospital of Shangqiu	Shangqiu	Henan
China	Yuebei People's Hospital	Shaoguan	Guangdong
China	The General Hospital of Shenyang Military	Shenyang	Liaoning
China	Shijiazhuang the Third Hospital	Shijiazhuang	Hebei
China	The Institute of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang
China	Wuhan NO.1 Hospital	Wuhan	Hubei
China	Shanxi Provincial People 's Hospital	Xi'an Shi	Shanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Xingtai Third Hospital	Xingtai	Hebei
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Xinxiang Central Hospital	Xinxiang	Henan
China	Xinyang Central Hospital	Xinyang	Henan
China	Xuchang Central Hospital	Xuchang	Henan
China	People's Hospital of Zhengzhou	Zhengzhou	Henan
China	The Fifth Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	The Medical Group of Zhengzhou First People's Hospital	Zhengzhou	Henan
China	Zhoukou Central Hospital	Zhoukou	Henan
China	Zhumadian Central Hospital	Zhumadian	Henan

Sponsors (3)

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

Country where clinical trial is conducted

China, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Death from any cause	3 months
Primary	Death	Death from any cause	6 months
Primary	Death	Death from any cause	12 months
Primary	Stroke recurrence	Ischemic stroke	3 months
Primary	Stroke recurrence	Ischemic stroke	6 months
Primary	Stroke recurrence	Ischemic stroke	12 months
Secondary	Hemorrhagic stroke	Cerebral hemorrhage and subaraclmoid hemorrhage	3 months
Secondary	Hemorrhagic stroke	Cerebral hemorrhage and subaraclmoid hemorrhage	6 months
Secondary	Hemorrhagic stroke	Cerebral hemorrhage and subaraclmoid hemorrhage	12 months
Secondary	Cardiovascular disease	Coronary heart disease and Angina pectoris	3 months
Secondary	Cardiovascular disease	Coronary heart disease and Angina pectoris	6 months
Secondary	Cardiovascular disease	Coronary heart disease and Angina pectoris	12 months
Secondary	Functional outcome	Modified Rankin Scale =3	3 months
Secondary	Functional outcome	Modified Rankin Scale =3	6 months
Secondary	Functional outcome	Modified Rankin Scale =3	12 months