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

• Conditions: Intracranial Atherosclerosis ICAS; Acute 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.

Study Timeline

• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Study Start: 2018-11-14
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-28
• Last Update Posted: 2020-03-31
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 550

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.

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)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Tongren Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Anzhen Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Chao-Yang hospital; 🇨🇳 Beijing, Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

General Hospital of Chinese Armed Police Forces; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Peking University International Hospital; 🇨🇳 Beijing, Beijing, China

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