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

Wei-Hai Xu

Status: Unknown

Conditions: Intracranial Atherosclerosis ICAS; Acute Ischemic Stroke AIS

Treatments: Drug: aggressive medical management

Study type: Observational

Funder types: Other

Identifiers

NCT03719820

HRMRI II

Details and patient eligibility

About

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).

Full 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.

Enrollment: 550 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

550 participants in 1 patient group

Intracranial Atherosclerosis

Description:

First-ever stroke patients attributed to intracranial artery stenosis (\> 50% or occlusion) who receive aggressive medical management

Treatment:

Drug: aggressive medical management