NCT03079674

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

44 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

1.7 years

First QC Date

March 9, 2017

Last Update Submit

May 9, 2017

Conditions

Keywords

transient Ischemic Attackminor Strokenon-disabling ischemic cerebrovascular eventsbiomarkerepidemiologyprognosis

Outcome Measures

Primary Outcomes (6)

  • Death

    Death from any cause

    3 months

  • Death

    Death from any cause

    6 months

  • Death

    Death from any cause

    12 months

  • Stroke recurrence

    Ischemic stroke

    3 months

  • Stroke recurrence

    Ischemic stroke

    6 months

  • Stroke recurrence

    Ischemic stroke

    12 months

Secondary Outcomes (9)

  • Hemorrhagic stroke

    3 months

  • Hemorrhagic stroke

    6 months

  • Hemorrhagic stroke

    12 months

  • Cardiovascular disease

    3 months

  • Cardiovascular disease

    6 months

  • +4 more secondary outcomes

Study Arms (1)

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

Interventions

observational only- no intervention

NICE patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • ≥18 years old
  • elapsed time from last episode to registry \<48 hours

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (44)

Chongqing Three Gorges Central Hospital

Chongqing, Chongqing Municipality, 404000, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Jiangmen Central Hospital

Jiangmen, Guangdong, 529000, China

Location

Yuebei People's Hospital

Shaoguan, Guangdong, 512026, China

Location

Shijiazhuang the Third Hospital

Shijiazhuang, Hebei, 050011, China

Location

Xingtai Third Hospital

Xingtai, Hebei, 054000, China

Location

Anyang People's Hospital

Anyang, Henan, 455000, China

Location

The People's Hospital of Hebi

Hebi, Henan, 458000, China

Location

The Second People 's Hospital of Jiaozuo

Jiaozuo, Henan, 454150, China

Location

The Huaihe Hospital of Henan University

Kaifeng, Henan, 475000, China

Location

Luohe Central Hospital

Luohe, Henan, 462000, China

Location

Luoyang Central Hospital Affiliated to Zhengzhou University

Luoyang, Henan, 471000, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471000, China

Location

Nanyang City Central Hospital

Nanyang, Henan, 473000, China

Location

Nanshi Hospital of Nanyang

Nanyang, Henan, 473065, China

Location

The First People's Hospital of Pingdingshan

Pingdingshan, Henan, 467000, China

Location

People's Hospital of Puyang

Puyang, Henan, 457000, China

Location

Sanmenxia Central Hospital

Sanmenxia, Henan, 472000, China

Location

The First People's Hospital of Shangqiu

Shangqiu, Henan, 476100, China

Location

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453000, China

Location

Xinxiang Central Hospital

Xinxiang, Henan, 453000, China

Location

Xinyang Central Hospital

Xinyang, Henan, 464000, China

Location

Xuchang Central Hospital

Xuchang, Henan, 461000, China

Location

The Fifth Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

The Medical Group of Zhengzhou First People's Hospital

Zhengzhou, Henan, 450000, China

Location

People's Hospital of Zhengzhou

Zhengzhou, Henan, 450003, China

Location

Zhoukou Central Hospital

Zhoukou, Henan, 466000, China

Location

Zhumadian Central Hospital

Zhumadian, Henan, 463000, China

Location

Jingmen No.1 People 's Hospital

Jingmen, Hubei, 448000, China

Location

Wuhan NO.1 Hospital

Wuhan, Hubei, 430022, China

Location

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, 014010, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The General Hospital of Shenyang Military

Shenyang, Liaoning, 110840, China

Location

Ankang HospitaL of Traditional Chinese Medicine

Ankang, Shanxi, 725000, China

Location

Fenyang Hospital

Fenyang, Shanxi, 032200, China

Location

Linfen People's Hospital

Linfen, Shanxi, 041000, China

Location

Shanxi Provincial People 's Hospital

Xi'an Shi, Shanxi, 710068, China

Location

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

Mianyang Central Hospital

Mianyang, Sichuan, 621000, China

Location

Nanchong Central Hospital

Nanchong, Sichuan, 637000, China

Location

The Institute of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830000, China

Location

Yan'an Affiliated Hospital to Kunming Medical University

Kunming, Yunnan, 650051, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650101, China

Location

Related Publications (14)

  • 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.

    PMID: 26998948BACKGROUND
  • 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.

    PMID: 21669116BACKGROUND
  • 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.

    PMID: 17993293BACKGROUND
  • 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.

    PMID: 18071162BACKGROUND
  • 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.

    PMID: 25957333BACKGROUND
  • 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.

    PMID: 21609414BACKGROUND
  • 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.

    PMID: 26027613BACKGROUND
  • 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.

    PMID: 26136519BACKGROUND
  • 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.

    PMID: 23532014BACKGROUND
  • 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.

    PMID: 24481975BACKGROUND
  • 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.

    PMID: 27056984BACKGROUND
  • 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.

    PMID: 27096581BACKGROUND
  • 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.

    PMID: 23803136BACKGROUND
  • 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.

    PMID: 25957224BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The faecal samples, plasma, serum and whole blood are retained to establish the biological samples library of NICE.

MeSH Terms

Conditions

Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yuming Xu, MD, PhD

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR
  • Yilong Wang, MD, PhD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuming Xu, MD, PhD

CONTACT

Yilong Wang, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 14, 2017

Study Start

June 1, 2017

Primary Completion

February 1, 2019

Study Completion

February 1, 2020

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations