Stroke Imaging Package Study

NCT02485275 — Completed, 949 participants, Wei-Hai Xu

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Registry	NCT02485275, acronym SIPS
Status	Completed
Study type	Observational
Enrollment	949 (Actual)
Sponsor	Wei-Hai Xu (Other); collaborators: Peking Union Medical College Hospital, Third Medical Center of Chinese PLA General Hospital, Army Medical Center of PLA, The General Hospital of Northern Theater Command, Subei People's Hospital of Jiangsu Province, Second Affiliated Hospital, Zhejiang University, School of Medicine, Beijing Jishuitan Hospital, Fujian Medical University Union Hospital, The First Hospital of Jilin University, The First Affiliated Hospital of University of South China, Qilu Hospital of Shandong University, Tangshan Gongren Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Renmin Hospital of Wuhan University, China-Japan Union Hospital, Jilin University, Shanghai Tong Ren Hospital
Conditions	Acute Ischemic Stroke, Intracranial Arteriosclerosis, Cerebral Small Vessel Diseases
Dates	start 2015-07-01, primary completion 2017-04-30, completion 2017-11-30, first posted 2015-06-30, last updated 2018-12-14
Locations	16 sites in China

-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.

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+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.

+Outcome measures

Primary outcomes

early neurological deterioration within 3 weeks after stroke onset (END-3 weeks) [3 weeks after stroke onset]: 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.
90-days prognosis [90-days after stroke onset]: 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.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

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

Exclusion Criteria:

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

+Locations (16)

Facility	City	Country
Beijing Jishuitan Hospital	Beijing, Beijing Municipality	China
The Third Medical Center of Chinese PLA General Hospital	Beijing, Beijing Municipality	China
Peking Union Medical College Hospital	Beijing, Beijing Municipality	China
Army Medical Center of PLA	Chongqing, Chongqing Municipality	China
Fujian Medical University Union Hospital	Fuzhou, Fujian	China
Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou, Guangdong	China
Tangshan Gongren Hospital	Tangshan, Hebei	China
Renmin Hospital of Wuhan University	Wuhan, Hubei	China
The First Affiliated Hospital of University of South China	Hengyang, Hunan	China
Subei People's Hospital of Jiangsu Province	Yangzhou, Jiangsu	China
The First Hospital of Jilin University	Changchun, Jilin	China
China-Japan Union Hospital of Jilin University	Changchun, Jilin	China
General Hospital of Northern Theater Command	Shenyang, Liaoning	China
Qilu Hospital of Shandong University	Qingdao, Shandong	China
Tongren Hospital, Shanghai Jiaotong University School of Medicine	Shanghai, Shanghai Municipality	China
Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou, Zhejiang	China

+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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 25666631
Results publication: 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 37452734