Transient Ischemic AttackCR-NICENCT03079674
China Registry of Non-disabling Ischemic Cerebrovascular Events
An observational study of Transient Ischemic Attack and Minor Stroke, run by The First Affiliated Hospital of Zhengzhou University at 44 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Ischemic Attack, Minor Stroke
- How many people
- 10,000 participants
- Where
- 44 sitesChina
- Study dates
- 1 Jun 2017to 1 Feb 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥18 years old
- elapsed time from last episode to registry <48 hours
Who cannot join
- patients who refused to participate in the research, and patients who failed to complete the follow-up protocol.
- patients with malignant tumors, or patients with severe liver or kidney disease, whose life expectancy is less than 1 year.
- patients who received endovascular or thrombolytic therapy.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
China44 sites
Ankang HospitaL of Traditional Chinese Medicine
Ankang, Shanxi, 725000
Pingkang Pan, 13992501998, 13992501998@163.com
Anyang People's Hospital
Anyang, Henan, 455000
Qingcheng Yang, MD, 13503728378, ay03728378@163.com
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014010
Chunyang Zhang, MD, 18047211234, zhangchunyang1964@163.com
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404000
Shengli Chen, MD, 13896226960, 2271487396@qq.com
Fenyang Hospital
Fenyang, Shanxi, 032200
Xueying Guo, MD, 13103581689, sxfygxy@163.com
The People's Hospital of Hebi
Hebi, Henan, 458000
Lizhong Li, MD, 13903922778, liliz55555@163.com
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Jianxin Zhong, MD, 13828071969, 2269897342@qq.com
Suipian Lai, MD, 13702583308, 1392237695@qq.com
The Second People 's Hospital of Jiaozuo
Jiaozuo, Henan, 454150
Xiangdong Xie, MD, 13839196919, 448998152@qq.com
Jingmen No.1 People 's Hospital
Jingmen, Hubei, 448000
Baohua Wang, MD, 13581328208, 378446495@qq.com
The Huaihe Hospital of Henan University
Kaifeng, Henan, 475000
Na Chang, MD, 18738989685, baogongci@126.com
Yan'an Affiliated Hospital to Kunming Medical University
Kunming, Yunnan, 650051
Liping Zhan, MD, 13668713827, 2510765864@qq.com
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650101
Yuhong Zhu, MD, 13708807578, 1760725487@qq.com
Linfen People's Hospital
Linfen, Shanxi, 041000
Chunping Chen, MD, 15034329988, pingchun9136@163.com
Luohe Central Hospital
Luohe, Henan, 462000
Luoyang Central Hospital Affiliated to Zhengzhou University
Luoyang, Henan, 471000
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000
Ganqin Du, MD, 13613882922, dgq99@163.com
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Hua Luo, MD, 13018154867, lzlh@sina.com
Mianyang Central Hospital
Mianyang, Sichuan, 621000
Jinfeng Duan, MD, 13908116541, duancs63@163.com
Yun Zhang, MD, 13890167700, 15032071@qq.com
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xiaoping Yin, PhD, 13870218146, xiaopingbuxiao@126.com
Nanchong Central Hospital
Nanchong, Sichuan, 637000
Yifei Ji, 18909074105, jiyifefi_2003@163.com
Nanyang City Central Hospital
Nanyang, Henan, 473000
Baochao Zhang, MD, 18538953366, zbc177777@163.com
Nanshi Hospital of Nanyang
Nanyang, Henan, 473065
Xinchen Zhu, MD, 13838789875, zxcfj2003@163.com
The First People's Hospital of Pingdingshan
Pingdingshan, Henan, 467000
Wenjun Xue, MD, 13393796518, xuewj08@163.com
People's Hospital of Puyang
Puyang, Henan, 457000
Shunqing Zhang, MD, 13619866163, 13619866163@163.com
Sanmenxia Central Hospital
Sanmenxia, Henan, 472000
Shufang Yao, MD, 15138163911, yaoshufang2008@126.com
The First People's Hospital of Shangqiu
Shangqiu, Henan, 476100
Yan Fang, MD, 13937050388, fangyan820@126.com
Yuebei People's Hospital
Shaoguan, Guangdong, 512026
Junbin Chen, MD, 13500205898, CJBCL0397@163.com
The General Hospital of Shenyang Military
Shenyang, Liaoning, 110840
Huisheng Chen, MD, PhD, 13352452086, chszh@aliyun.com
Shijiazhuang the Third Hospital
Shijiazhuang, Hebei, 050011
Yunshu Zhang, 13323115965, 13323115965@163.com
The Institute of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830000
Xinling Meng, MD, 13999820954, liujia7810@163.com
Wuhan NO.1 Hospital
Wuhan, Hubei, 430022
Guohua Chen, MD, PhD, 13971318512, cghys2008@126.com
Shanxi Provincial People 's Hospital
Xi'an Shi, Shanxi, 710068
Qian Yang, MD, 13379213866, yangqdoctor@163.com
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Jianpeng Li, PhD, 13860192261, 806469536@qq.com
Xingtai Third Hospital
Xingtai, Hebei, 054000
Yongmei Kong, MD, 13603193670, xtsykym@126.com
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453000
Ping Zhang, MD, 13673732099, zhangpingsjnk@163.com
Xinxiang Central Hospital
Xinxiang, Henan, 453000
Cheng Miao, MD, 18339502871, miaochen01@126.com
Xinyang Central Hospital
Xinyang, Henan, 464000
Jianjun Chang, MD, 13503761500, 877827405@qq.com
Xuchang Central Hospital
Xuchang, Henan, 461000
Shude You, MD, 13903990688, ysd6935@163.com
The Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Yuanhong He, MD, 13837135369, hyhcmf@163.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Yuming Xu, MD, PhD, 13903711125, xuyuming@zzu.edu.cn
The Medical Group of Zhengzhou First People's Hospital
Zhengzhou, Henan, 450000
Xiaoman Zhang, MD, 13838566918, zhangxiaoman2@126.com
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450003
Daopei Zhang, MD, 13903869251, zhangdaopei89@163.com
Zhoukou Central Hospital
Zhoukou, Henan, 466000
Lei Xia, MD, 18639493636, 391114308@qq.com
Zhumadian Central Hospital
Zhumadian, Henan, 463000
Ligong Gao, MD, 13703961919, 13703961919@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Transient Ischemic Attack, Minor Stroke
- Being tested
- observational only- no intervention
- Keywords
- transient Ischemic Attack, minor Stroke, non-disabling ischemic cerebrovascular events, biomarker, epidemiology, prognosis
- Medical subject headings
- Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational only- no interventionOther
observational only- no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: observational only- no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death from any cause
Measured: 3 months
Death
Death from any cause
Measured: 6 months
Death
Death from any cause
Measured: 12 months
Stroke recurrence
Ischemic stroke
Measured: 3 months
Stroke recurrence
Ischemic stroke
Measured: 6 months
Stroke recurrence
Ischemic stroke
Measured: 12 months
Secondary outcomes (9)
Hemorrhagic stroke
Cerebral hemorrhage and subaraclmoid hemorrhage
Measured: 3 months
Hemorrhagic stroke
Cerebral hemorrhage and subaraclmoid hemorrhage
Measured: 6 months
Hemorrhagic stroke
Cerebral hemorrhage and subaraclmoid hemorrhage
Measured: 12 months
Cardiovascular disease
Coronary heart disease and Angina pectoris
Measured: 3 months
Cardiovascular disease
Coronary heart disease and Angina pectoris
Measured: 6 months
Cardiovascular disease
Coronary heart disease and Angina pectoris
Measured: 12 months
Functional outcome
Modified Rankin Scale ≥3
Measured: 3 months
Functional outcome
Modified Rankin Scale ≥3
Measured: 6 months
Functional outcome
Modified Rankin Scale ≥3
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Feb 2019 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Transient Ischemic AttackStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Family Planning Commission, P.R.China, Beijing Tiantan Hospital
- Responsible party
- Principal investigator, Yuming-Xu, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Yuming Xu, MD, PhD, Principal investigator, The First Affiliated Hospital of Zhengzhou UniversityYilong Wang, MD, PhD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079674
- Sponsor's protocol ID
- GN-2016R0009
- Acronym
- CR-NICE
- Status last verified
- May 2017
- First submitted
- 9 Mar 2017
- Last updated
- 11 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26998948Meng 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.
PubMed 21669116Giles 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.
PubMed 17993293Wu 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.
PubMed 18071162Wang 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.
PubMed 25957333Wang 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.
PubMed 21609414Wang 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.
PubMed 26027613Wardlaw 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.
PubMed 26136519Song 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.
PubMed 23532014Wang 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.
PubMed 24481975Suri 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.
PubMed 27056984Amarenco 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.
PubMed 27096581Wang 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.
PubMed 23803136Wang 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.
PubMed 25957224
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Registry of Non-disabling Ischemic Cerebrovascular Events: A Prospective Multi-center, National Registry Trail
- ClinicalTrials.gov ID
- NCT03079674
- Acronym / sponsor ID
- CR-NICE / GN-2016R0009
- Conditions
- Transient Ischemic Attack, Minor Stroke
- Keywords
- transient Ischemic Attack, minor Stroke, non-disabling ischemic cerebrovascular events, biomarker, epidemiology, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- National Health and Family Planning Commission, P.R.China, Beijing Tiantan Hospital
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NICE patients | – | Other: observational only- no interventionNon-disabling ischemic cerebrovascular events patients indicate patients with transient ischemic attack and minor stroke (National Institute of Health stroke scale, NIHSS≤3). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- ≥18 years old
- elapsed time from last episode to registry <48 hours
Key exclusion criteria (3 listed)
- patients who refused to participate in the research, and patients who failed to complete the follow-up protocol.
- patients with malignant tumors, or patients with severe liver or kidney disease, whose life expectancy is less than 1 year.
- patients who received endovascular or thrombolytic therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational only- no interventionobservational only- no intervention | Other | NICE patients |
Primary outcome
Death
Time frame: 3 months
Death from any cause
Death
Time frame: 6 months
Death from any cause
Death
Time frame: 12 months
Death from any cause
Stroke recurrence
Time frame: 3 months
Ischemic stroke
Stroke recurrence
Time frame: 6 months
Ischemic stroke
Stroke recurrence
Time frame: 12 months
Ischemic stroke
9 secondary outcomes
Hemorrhagic stroke
Time frame: 3 months
Hemorrhagic stroke
Time frame: 6 months
Hemorrhagic stroke
Time frame: 12 months
Cardiovascular disease
Time frame: 3 months
Cardiovascular disease
Time frame: 6 months
Cardiovascular disease
Time frame: 12 months
Functional outcome
Time frame: 3 months
Functional outcome
Time frame: 6 months
Functional outcome
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Background: PubMed 26998948Yaghi 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.
- Background: PubMed 21669116Meng 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.
- Background: PubMed 17993293Giles 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.
- Background: PubMed 18071162Wu 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.
- Background: PubMed 25957333Wang 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.
- Background: PubMed 21609414Wang 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.
- Background: PubMed 26027613Wang 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.
- Background: PubMed 26136519Wardlaw 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.
- Background: PubMed 23532014Song 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.
- Background: PubMed 24481975Wang 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.
- Background: PubMed 27056984Suri 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.
- Background: PubMed 27096581Amarenco 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.
- Individual participant dataSharing planned: Undecided
Related trials for Transient Ischemic Attack
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingPhase 3
Upfront Lipid-Lowering Therapy With Statins Combined With Hybutimibe in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.
Ischemia Stroke, TIA (Transient Ischemic Attack)
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuming Xu, MD, PhD principal investigator
The First Affiliated Hospital of Zhengzhou University
Yilong Wang, MD, PhD principal investigator
Beijing Tiantan Hospital
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transient Ischemic Attack and Minor Stroke, run by The First Affiliated Hospital of Zhengzhou University at 44 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuming Xu, MD, PhD (86-13903711125, xuyuming@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079674, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.