NCT02485275

Brief Summary

Our study aims to explore the value of new imaging technique package in predicting early neurological deterioration (END) as well as 90-day unfavorable outcome in patients with acute ischaemic stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
949

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
1 country

16 active sites

Status
completed

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

June 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

December 14, 2018

Status Verified

December 1, 2018

Enrollment Period

1.8 years

First QC Date

June 25, 2015

Last Update Submit

December 12, 2018

Conditions

Acute Ischemic StrokeIntracranial ArteriosclerosisCerebral Small Vessel Diseases

Keywords

AISICASCSVD

Outcome Measures

Primary Outcomes (2)

  • early neurological deterioration within 3 weeks after stroke onset (END-3 weeks)

    END-3 weeks is defined as a significant neuro-functional decline \[increment of the National Institutes of Health Stroke Scale (NIHSS) ≥ 2 points \] within 3 weeks after admission.

    3 weeks after stroke onset

  • 90-days prognosis

    90-days prognosis included two parts :1) stroke recurrence with new lesion on DWI;2) the modified Ranking Score (mRS) at 90-days after stroke onset.

    90-days after stroke onset

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from the collaborative stroke centers and will be followed for the duration of their hospitalization. Patients will be followed up until at least 3 months after stroke onset.

You may qualify if:

  • patients with ischemic stroke and hospitalized during 4.5-72 hours after onset , confirmed by diffusion weighted imaging (DWI).
  • patients with stable vital signs.
  • patients who have underwent thrombolytic/intravascular therapy are allowed to enroll in the study.

You may not qualify if:

  • patients with absolute/relative contraindication to MRI (including but not confined to metal in the body and claustrophobia).
  • patients who is extremely agitated, and cannot comply with MRI exam.
  • patients who declined the consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100038, China

Location

The Third Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Army Medical Center of PLA

Chongqing, Chongqing Municipality, 400042, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

Location

Tangshan Gongren Hospital

Tangshan, Hebei, 063000, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 421001, China

Location

Subei People's Hospital of Jiangsu Province

Yangzhou, Jiangsu, 225001, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

China-Japan Union Hospital of Jilin University

Changchun, Jilin, 130033, China

Location

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110840, China

Location

Qilu Hospital of Shandong University

Qingdao, Shandong, 266555, China

Location

Tongren Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200050, China

Location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (9)

  • Mazighi M, Labreuche J, Gongora-Rivera F, Duyckaerts C, Hauw JJ, Amarenco P. Autopsy prevalence of intracranial atherosclerosis in patients with fatal stroke. Stroke. 2008 Apr;39(4):1142-7. doi: 10.1161/STROKEAHA.107.496513. Epub 2008 Feb 28.

    PMID: 18309170BACKGROUND

  • Li ML, Xu WH, Song L, Feng F, You H, Ni J, Gao S, Cui LY, Jin ZY. Atherosclerosis of middle cerebral artery: evaluation with high-resolution MR imaging at 3T. Atherosclerosis. 2009 Jun;204(2):447-52. doi: 10.1016/j.atherosclerosis.2008.10.019. Epub 2008 Oct 25.

    PMID: 19041971BACKGROUND

  • Xu WH, Li ML, Gao S, Ni J, Zhou LX, Yao M, Peng B, Feng F, Jin ZY, Cui LY. In vivo high-resolution MR imaging of symptomatic and asymptomatic middle cerebral artery atherosclerotic stenosis. Atherosclerosis. 2010 Oct;212(2):507-11. doi: 10.1016/j.atherosclerosis.2010.06.035. Epub 2010 Jun 25.

    PMID: 20638663BACKGROUND

  • Xu WH, Li ML, Gao S, Ni J, Zhou LX, Yao M, Peng B, Feng F, Jin ZY, Cui LY. Plaque distribution of stenotic middle cerebral artery and its clinical relevance. Stroke. 2011 Oct;42(10):2957-9. doi: 10.1161/STROKEAHA.111.618132. Epub 2011 Jul 28.

    PMID: 21799160BACKGROUND

  • Xu WH, Li ML, Gao S, Ni J, Yao M, Zhou LX, Peng B, Feng F, Jin ZY, Cui LY. Middle cerebral artery intraplaque hemorrhage: prevalence and clinical relevance. Ann Neurol. 2012 Feb;71(2):195-8. doi: 10.1002/ana.22626.

    PMID: 22367991BACKGROUND

  • Xu WH, Li ML, Niu JW, Feng F, Jin ZY, Gao S. Intracranial artery atherosclerosis and lumen dilation in cerebral small-vessel diseases: a high-resolution MRI Study. CNS Neurosci Ther. 2014 Apr;20(4):364-7. doi: 10.1111/cns.12224. Epub 2014 Jan 15.

    PMID: 24423003BACKGROUND

  • Xu WH, Li ML, Niu JW, Feng F, Jin ZY, Gao S. Deep tiny flow voids along middle cerebral artery atherosclerotic occlusions: a high-resolution MR imaging study. J Neurol Sci. 2014 Apr 15;339(1-2):130-3. doi: 10.1016/j.jns.2014.01.042. Epub 2014 Feb 6.

    PMID: 24530171BACKGROUND

  • Li M, Wu SW, Xu WH. High-resolution MRI of radiation-induced intracranial vasculopathy. Neurology. 2015 Feb 10;84(6):631. doi: 10.1212/WNL.0000000000001223. No abstract available.

    PMID: 25666631BACKGROUND

  • Zhang ZM, Si QQ, Chen HS, Yang Y, Zhang M, Wu SW, Meng Y, Li ML, Lin QQ, Liebeskind DS, Huang YN, Xu WH. High-resolution magnetic resonance imaging of acute intracranial artery thrombus. Eur J Neurol. 2023 Oct;30(10):3172-3181. doi: 10.1111/ene.15985. Epub 2023 Aug 7.

    PMID: 37452734DERIVED

MeSH Terms

Conditions

Ischemic StrokeIntracranial ArteriosclerosisCerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial Arterial DiseasesArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 25, 2015

First Posted

June 30, 2015

Study Start

July 1, 2015

Primary Completion

April 30, 2017

Study Completion

November 30, 2017

Last Updated

December 14, 2018

Record last verified: 2018-12

Locations

CN(16)