Stroke Imaging Package Study of Intracranial Atherosclerosis ( SIPS-ICAS )
- Conditions
- Intracranial Atherosclerosis ICASAcute Ischemic Stroke AIS
- Interventions
- Drug: aggressive medical management
- Registration Number
- NCT03719820
- Lead Sponsor
- Wei-Hai Xu
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 550
- Age 35-80 years old
- First-ever stroke patients confirmed by diffusion weighted imaging (DWI) attributed to intracranial artery stenosis (> 50%) within 7 days after onset.
- Patients with stable vital signs.
- Patients who have underwent thrombolytic/intravascular therapy are allowed to enroll in the study.
- Patients with > 50% ipsilateral carotid artery stenosis, cardiac embolism ,and any other stroke etiologies such as vasculitis, dissection or other causes.
- Patients with absolute/relative contraindication to MRI (including but not confined to metal in the body and claustrophobia).
- Patients who cannot comply with MRI exam.
- Patients who decline the consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intracranial Atherosclerosis aggressive medical management First-ever stroke patients attributed to intracranial artery stenosis (\> 50% or occlusion) who receive aggressive medical management
- Primary Outcome Measures
Name Time Method Number of Participants with stroke recurrence 12 months after stroke onset stroke recurrence with new lesions on DWI
poor functional outcome 90 day after stroke onset 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.
Evolution of intracranial atherosclerosis burden 6 months after stroke onset Changes of plaque and thrombus volume on HR-MRI images at the admission and the follow-up
- Secondary Outcome Measures
Name Time Method Number of Participants with Death due to Heart Disease, Cerebravascular Disease or Other Vascular Etiology 12 months after stroke onset death due to stroke, intracranial hemorrhage,heart attack,heart failure, arrhythmia,pulmonary embolism,visceral hemorrhage or other vascular etiology
Trial Locations
- Locations (38)
Nanshi Hospital of Nanyang
🇨🇳Nanyang, Henan, China
Affiliated Taihe Hospital of Hubei University of Medicine
🇨🇳Shiyan, Hubei, China
General Hospital of Shen Yang Millitary Command
🇨🇳Shenyang, Liaoning, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
Qilu Hospital of Shandong University (Qingdao)
🇨🇳Qingdao, Shandong, China
Weihai Municipal Hospital
🇨🇳Weihai, Shandong, China
Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Changzhi People's Hospital
🇨🇳Changzhi, Shanxi, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Hong Xinglong Central Hospital
🇨🇳Shuangyashan, Heilongjiang, China
Beijing Tongren Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Peking University International Hospital
🇨🇳Beijing, Beijing, China
Tangshan Gongren Hospital
🇨🇳Tangshan, Hebei, China
Subei People's Hospital of Jiangsu Province
🇨🇳Yangzhou, Jiangsu, China
The Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Tongji Hospital, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
JiNing NO.1 People Hospital
🇨🇳Jining, Shandong, China
First Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Taiyuan Central Hospital of Shanxi Meidical University
🇨🇳Taiyuan, Shanxi, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Beijing Anzhen Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Chao-Yang hospital
🇨🇳Beijing, Beijing, China
The first affiliated hospital affiliated to AMU (Southwest Hospital)
🇨🇳Chongqing, Chongqing, China
General Hospital of Chinese Armed Police Forces
🇨🇳Beijing, Beijing, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
The First Affiliated Hospital of University of South China
🇨🇳Hengyang, Hunan, China
The University of HongKong-Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Hebei General Hospital
🇨🇳Shijiazhuang, Hebei, China
China-Japan Union Hospital, Jilin University
🇨🇳Changchun, Jilin, China
Tongren Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
People's Hospital Ningxia Hui Autonomous Region
🇨🇳Yinchuan, Ningxia, China
Zhejiang Provincial Tongde Hospital
🇨🇳Hangzhou, Zhejiang, China
Beijing Friendship Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China