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Acute Ischemic StrokeSIPSNCT02485275

Stroke Imaging Package Study

An observational study of Acute Ischemic Stroke and Intracranial Arteriosclerosis, run by Wei-Hai Xu at 16 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
949 participants
Where
16 sitesChina
Study dates
1 Jul 2015to 30 Nov 2017
How long will I take part?
3 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, 100038

  • The Third Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100039

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033

  • Army Medical Center of PLA

    Chongqing, Chongqing Municipality, 400042

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510630

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310009

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan, 421001

  • Qilu Hospital of Shandong University

    Qingdao, Shandong, 266555

  • Tongren Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200050

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning, 110840

  • Tangshan Gongren Hospital

    Tangshan, Hebei, 063000

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Subei People's Hospital of Jiangsu Province

    Yangzhou, Jiangsu, 225001

Other trials in China

About this study

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.

Read the detailed description
  1. Patients with acute ischemic stroke within 4.5-72h after onset were prospectively enrolled in our study and underwent standardized clinical and new imaging technique package assessment.
  2. New imaging technique package mainly includes conventional cranial MRI （T1,T2,T2 FLAIR,DWI, and ADC), cranial magnetic resonance angiography (MRA), and intracranial vessel wall imaging (High-Resolution Magnetic Resonance Imaging,HRMRI) as well as susceptibility weighted imaging (SWI).
  3. The neurofunctional fluctuation during hospitalization as well as 90-day outcomes were carefully assessed. Patients were followed up for 90-days after stroke onset.
  4. 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.
Keywords
AIS, ICAS, CSVD
Medical subject headings
Ischemic Stroke, Intracranial Arteriosclerosis, Cerebral Small Vessel Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 weeks after stroke onset

  2. 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.

    Measured: 90-days after stroke onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2015 (estimated)
  2. Study start1 Jul 2015
  3. Primary completion30 Apr 2017
  4. Study completion30 Nov 2017

Resources

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
949 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02485275
Sponsor's protocol ID
HRMRI
Acronym
SIPS
Status last verified
Dec 2018
First submitted
25 Jun 2015
Last updated
14 Dec 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18309170

  • 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.

    PubMed 19041971

  • 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.

    PubMed 20638663

  • 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.

    PubMed 21799160

  • 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.

    PubMed 22367991

  • 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.

    PubMed 24423003

  • 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.

    PubMed 24530171

  • 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.

    PubMed 25666631

  • 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.

    PubMed 37452734

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Ischemic Stroke and Intracranial Arteriosclerosis, run by Wei-Hai Xu at 16 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 3 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: finished, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

early neurological deterioration within 3 weeks after stroke onset (END-3 weeks) (time frame: 3 weeks after stroke onset). The study lists 2 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 NCT02485275, which also lists 9 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 14 Dec 2018.

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