Acute Ischemic Stroke AIS, Intracranial Atherosclerosis ICAS
Conditions
Keywords
Acute Ischemic Stroke, Intracranial Atherosclerosis ICAS, HRMRI
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.
Interventions
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
Sponsors
Peking Union Medical College Hospital
General Hospital of Chinese Armed Police Forces
General Hospital of Shenyang Military Region
Subei People's Hospital of Jiangsu Province
Fujian Medical University Union Hospital
Tangshan Gongren Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Qingdao Municipal Hospital
West China Hospital
Shanghai Tong Ren Hospital
Ruijin Hospital
The First Affiliated Hospital of University of South China
JiNing NO.1 People Hospital
Tongji Hospital
The University of HongKong-Shenzhen Hospital
Beijing Anzhen Hospital
Beijing Hospital
Peking University International Hospital
Beijing Tongren Hospital
China-Japan Friendship Hospital
Peking University First Hospital
Beijing Friendship Hospital
Beijing Chao Yang Hospital
Qilu Hospital of Shandong University (Qingdao)
Shandong Provincial Hospital
The Second Hospital of Hebei Medical University
Hebei General Hospital
First Affiliated Hospital of Zhejiang University
China-Japan Union Hospital, Jilin University
Zhejiang Provincial Tongde Hospital
People's Hospital of Ningxia Hui Autonomous Region
Taiyuan Central Hospital of Shanxi Medical University
Hong Xinglong Central Hospital
Changzhi People's Hospital
Weihai Municipal Hospital
Southwest Hospital, China
Affiliated Taihe Hospital of Hubei University of Medicine
Nanshi Hospital of Nanyang
Wei-Hai Xu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Participants with stroke recurrence | 12 months after stroke onset | stroke recurrence with new lesions on DWI |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events That Are Related to Anti-platelet Treatment | 12 months after stroke onset | intracranial bleeding confirmed by CT，fatal bleeding causing hemodynamic abnormalities needed blood tranfusion or surgical intervention |
| Number of Participants with Adverse Events That Are Related to StatinTreatment | 12 months after stroke onset | more than 3-fold liver enzyme increase，rhabdomyolysis |
Countries
China
Contacts
Primary ContactWeihai Xu, MD
Backup ContactYining Huang, MD
Outcome results
None listed