Clinical trial NCT03719820: Stroke Imaging Package Study of Intracranial Atherosclerosis ( SIPS-ICAS )
Official title: Stroke Imaging Package Study of Intracranial Atherosclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke AIS
Intracranial Atherosclerosis ICAS
Keywords: Acute Ischemic Stroke
Intracranial Atherosclerosis ICAS
HRMRI
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: General Hospital of Chinese Armed Police Forces
name: General Hospital of Shenyang Military Region
name: Subei People's Hospital of Jiangsu Province
name: Fujian Medical University Union Hospital
name: Tangshan Gongren Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Qingdao Municipal Hospital
name: West China Hospital
name: Shanghai Tong Ren Hospital
name: Ruijin Hospital
name: The First Affiliated Hospital of University of South China
name: JiNing NO.1 People Hospital
name: Tongji Hospital
name: The University of HongKong-Shenzhen Hospital
name: Beijing Anzhen Hospital
name: Beijing Hospital
name: Peking University International Hospital
name: Beijing Tongren Hospital
name: China-Japan Friendship Hospital
name: Peking University First Hospital
name: Beijing Friendship Hospital
name: Beijing Chao Yang Hospital
name: Qilu Hospital of Shandong University (Qingdao)
name: Shandong Provincial Hospital
name: The Second Hospital of Hebei Medical University
name: Hebei General Hospital
name: First Affiliated Hospital of Zhejiang University
name: China-Japan Union Hospital, Jilin University
name: Zhejiang Provincial Tongde Hospital
name: People's Hospital of Ningxia Hui Autonomous Region
name: Taiyuan Central Hospital of Shanxi Medical University
name: Hong Xinglong Central Hospital
name: Changzhi People's Hospital
name: Weihai Municipal Hospital
name: Southwest Hospital, China
name: Affiliated Taihe Hospital of Hubei University of Medicine
name: Nanshi Hospital of Nanyang
First posted: 2018-10-25
Enrollment: 550
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital based population

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: poor functional outcome
timeFrame: 90 day after stroke onset
measure: Number of Participants with stroke recurrence
timeFrame: 12 months after stroke onset
measure: Evolution of intracranial atherosclerosis burden
timeFrame: 6 months after stroke onset
Secondary outcomes:
measure: Number of Participants with Death due to Heart Disease, Cerebravascular Disease or Other Vascular Etiology
timeFrame: 12 months after stroke onset
Other outcomes:
measure: Number of Participants with Adverse Events That Are Related to Anti-platelet Treatment
timeFrame: 12 months after stroke onset
measure: Number of Participants with Adverse Events That Are Related to StatinTreatment
timeFrame: 12 months after stroke onset
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Anzhen Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Chao-Yang hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: General Hospital of Chinese Armed Police Forces
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University International Hospital
state: Beijing
city: Chongqing
country: China
facility: The first affiliated hospital affiliated to AMU (Southwest Hospital)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: The University of HongKong-Shenzhen Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Tangshan
country: China
facility: Tangshan Gongren Hospital
state: Hebei
city: Shuangyashan
country: China
facility: Hong Xinglong Central Hospital
state: Heilongjiang
city: Nanyang
country: China
facility: Nanshi Hospital of Nanyang
state: Henan
city: Shiyan
country: China
facility: Affiliated Taihe Hospital of Hubei University of Medicine
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Yangzhou
country: China
facility: Subei People's Hospital of Jiangsu Province
state: Jiangsu
city: Changchun
country: China
facility: China-Japan Union Hospital, Jilin University
state: Jilin
city: Shenyang
country: China
facility: General Hospital of Shen Yang Millitary Command
state: Liaoning
city: Yinchuan
country: China
facility: People's Hospital Ningxia Hui Autonomous Region
state: Ningxia
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jining
country: China
facility: JiNing NO.1 People Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Qingdao
country: China
facility: Qilu Hospital of Shandong University (Qingdao)
state: Shandong
city: Weihai
country: China
facility: Weihai Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Tongren Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Changzhi
country: China
facility: Changzhi People's Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Taiyuan Central Hospital of Shanxi Meidical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial Tongde Hospital
state: Zhejiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Weihai Xu, MD
role: STUDY_CHAIR
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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. No abstract available.
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