Stroke Imaging Package Study

Acute Ischemic Stroke Clinical Trial

— SIPS  

Official title:

Stroke Imaging Package Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485275
• Other study ID #: HRMRI
• Status: Completed
• Start date: July 1, 2015
• Est. completion date: November 30, 2017

Study information

• Verified date: December 2018
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 949
• Est. completion date: November 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Arteriosclerosis
• Cerebral Small Vessel Diseases
• Intracranial Arteriosclerosis
• Stroke

Locations

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

Sponsors (17)

Lead Sponsor

Collaborator

Wei-Hai Xu

Army Medical Center of PLA, Beijing Jishuitan Hospital, China-Japan Union Hospital, Jilin University, First Hospital of Jilin University, Fujian Medical University Union Hospital, General Hospital of Northern Theater Command, Peking Union Medical College Hospital, Qilu Hospital of Shandong University, Renmin Hospital of Wuhan University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Tong Ren Hospital, Subei People's Hospital of Jiangsu Province, Tangshan Gongren Hospital, The First Affiliated Hospital of University of South China, The Third Medical Center of Chinese PLA General Hospital, Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. Erratum in: Atherosclerosis. 2011 Jul;217(1):296. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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