Stroke Imaging Package Study of Intracranial Atherosclerosis ( SIPS-ICAS )

Acute Ischemic Stroke AIS Clinical Trial

— SIPS-ICAS  

Official title:

Stroke Imaging Package Study of Intracranial Atherosclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03719820
• Other study ID #: HRMRI II
• Status: Recruiting
• Start date: November 14, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2020
• Source: Peking Union Medical College Hospital
• Contact: Weihai Xu, MD
• Phone: 010-69156114
• Email: xuwh[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A prospective, multicenter, cohort study to explore the stroke mechanisms of symptomatic intracranial atherosclerosis, the dynamic changes under aggressive medical treatment and their associations with clinical events using conventional MRI sequences plus high-resolution magnetic resonance (HR-MRI).

Description:

1. First-ever stroke patients attributed to intracranial artery stenosis (> 50% or occlusion) within 7 days after onset will be prospectively enrolled in our study and undergo new imaging technique package assessment at baseline.

2. The imaging technique package includes conventional cranial MRI （T1,T2,T2 FLAIR,DWI), cranial magnetic resonance angiography (MRA),high-resolution magnetic resonance (HR-MRI) and susceptibility weighted imaging (SWI) or T2*-weighted imaging.

3. Enrolled patients are recommended to receive aggressive medical management consisted of Aspirin (100 mg daily) and Clopidogrel (75 mg daily) for 3 months and Rosuvastatin (20mg daily) for at least 6 months as well as traditional risk factors management.

4. Patients were followed up for mRS score, stroke recurrence, medication compliance and laboratory examination including blood routine tests, liver functions and creatine kinase et al at 3 months, 6 months and 12 months after stroke onset. Additionally, patients are required to retake new HRMRI imaging of brain at 6 months.Remote patient education by We-Chat will be performed.

5. Our study aims to explore the stroke mechanisms of symptomatic intracranial atherosclerosis, the dynamic changes under aggressive medical treatment and their associations with clinical events using conventional MRI sequences plus HR-MRI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 35-80 years old

2. First-ever stroke patients confirmed by diffusion weighted imaging (DWI) attributed to intracranial artery stenosis (> 50%) within 7 days after onset.

3. Patients with stable vital signs.

4. Patients who have underwent thrombolytic/intravascular therapy are allowed to enroll in the study.

Exclusion Criteria:

1. Patients with > 50% ipsilateral carotid artery stenosis, cardiac embolism ,and any other stroke etiologies such as vasculitis, dissection or other causes.

2. Patients with absolute/relative contraindication to MRI (including but not confined to metal in the body and claustrophobia).

3. Patients who cannot comply with MRI exam.

4. Patients who decline the consent.

Related Conditions & MeSH terms

• Acute Ischemic Stroke AIS
• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis ICAS
• Stroke

Intervention

Drug:
• aggressive medical management
Aspirin (100 mg daily) and Clopidogrel (75 mg daily) for 3 months and Rosuvastatin (20mg daily) for at least 6 months as well as traditional risk factors management

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital Capital Medical University	Beijing	Beijing
China	Beijing Chao-Yang hospital	Beijing	Beijing
China	Beijing Friendship Hospital Capital Medical University	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Beijing Tongren Hospital Capital Medical University	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	General Hospital of Chinese Armed Police Forces	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University International Hospital	Beijing	Beijing
China	China-Japan Union Hospital, Jilin University	Changchun	Jilin
China	Changzhi People's Hospital	Changzhi	Shanxi
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The first affiliated hospital affiliated to AMU (Southwest Hospital)	Chongqing	Chongqing
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Provincial Tongde Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of University of South China	Hengyang	Hunan
China	Shandong Provincial Hospital	Jinan	Shandong
China	JiNing NO.1 People Hospital	Jining	Shandong
China	Nanshi Hospital of Nanyang	Nanyang	Henan
China	Qilu Hospital of Shandong University (Qingdao)	Qingdao	Shandong
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Tongren Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	General Hospital of Shen Yang Millitary Command	Shenyang	Liaoning
China	The University of HongKong-Shenzhen Hospital	Shenzhen	Guangdong
China	Hebei General Hospital	Shijiazhuang	Hebei
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Affiliated Taihe Hospital of Hubei University of Medicine	Shiyan	Hubei
China	Hong Xinglong Central Hospital	Shuangyashan	Heilongjiang
China	Taiyuan Central Hospital of Shanxi Meidical University	Taiyuan	Shanxi
China	Tangshan Gongren Hospital	Tangshan	Hebei
China	Weihai Municipal Hospital	Weihai	Shandong
China	Tongji Hospital, Huazhong University of Science and Technology	Wuhan	Hubei
China	Subei People's Hospital of Jiangsu Province	Yangzhou	Jiangsu
China	People's Hospital Ningxia Hui Autonomous Region	Yinchuan	Ningxia

Sponsors (39)

Lead Sponsor

Collaborator

Wei-Hai Xu

Affiliated Taihe Hospital of Hubei University of Medicine, Beijing Anzhen Hospital, Beijing Chao Yang Hospital, Beijing Friendship Hospital, Beijing Hospital, Beijing Tongren Hospital, Changzhi People's Hospital, China-Japan Friendship Hospital, China-Japan Union Hospital, Jilin University, First Affiliated Hospital of Zhejiang University, Fujian Medical University Union Hospital, General Hospital of Chinese Armed Police Forces, General Hospital of Shenyang Military Region, Hebei General Hospital, Hong Xinglong Central Hospital, JiNing NO.1 People Hospital, Nanshi Hospital of Nanyang, Peking Union Medical College Hospital, Peking University First Hospital, Peking University International Hospital, People's Hospital of Ningxia Hui Autonomous Region, Qilu Hospital of Shandong University (Qingdao), Qingdao Municipal Hospital, Shandong Provincial Hospital, Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai Tong Ren Hospital, Subei People's Hospital of Jiangsu Province, Taiyuan Central Hospital of Shanxi Medical University, Tangshan Gongren Hospital, The First Affiliated Hospital of University of South China, The first hospital affiliated to AMU (Southwest Hospital), The Second Hospital of Hebei Medical University, The University of HongKong-Shenzhen Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Tongji Hospital, Weihai Municipal Hospital, West China Hospital, Zhejiang Provincial Tongde Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

Derdeyn CP, Chimowitz MI, Lynn MJ, Fiorella D, Turan TN, Janis LS, Montgomery J, Nizam A, Lane BF, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Lynch JR, Zaidat OO, Rumboldt Z, Cloft HJ; Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial Investigators. Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial. Lancet. 2014 Jan 25;383(9914):333-41. doi: 10.1016/S0140-6736(13)62038-3. Epub 2013 Oct 26. — View Citation

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

Xu YY, Li ML, Gao S, Hou B, Sun ZY, Zhou HL, Feng F, Xu WH. Non-moyamoya vessel network formation along steno-occlusive middle cerebral artery. Neurology. 2016 May 24;86(21):1957-63. doi: 10.1212/WNL.0000000000002698. Epub 2016 Apr 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Adverse Events That Are Related to Anti-platelet Treatment	intracranial bleeding confirmed by CT,fatal bleeding causing hemodynamic abnormalities needed blood tranfusion or surgical intervention	12 months after stroke onset
Other	Number of Participants with Adverse Events That Are Related to StatinTreatment	more than 3-fold liver enzyme increase,rhabdomyolysis	12 months after stroke onset
Primary	poor functional outcome	The Rankin Score runs from 0-6, running from perfect health without symptoms to death. mRS 0-2 are defined as favorable outcomes while mRS 3-6 as unfavorable outcomes.0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead.	90 day after stroke onset
Primary	Number of Participants with stroke recurrence	stroke recurrence with new lesions on DWI	12 months after stroke onset
Primary	Evolution of intracranial atherosclerosis burden	Changes of plaque and thrombus volume on HR-MRI images at the admission and the follow-up	6 months after stroke onset
Secondary	Number of Participants with Death due to Heart Disease, Cerebravascular Disease or Other Vascular Etiology	death due to stroke, intracranial hemorrhage,heart attack,heart failure, arrhythmia,pulmonary embolism,visceral hemorrhage or other vascular etiology	12 months after stroke onset