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

March 28, 2020 updated by: Wei-Hai Xu

Stroke Imaging Package Study of Intracranial Atherosclerosis

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing, China, 100010
        • Recruiting
        • Beijing Hospital
        • Contact:
      • Beijing, Beijing, China, 100010
        • Not yet recruiting
        • Beijing Tongren Hospital Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Anzhen Hospital Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100020
        • Not yet recruiting
        • Beijing Chao-Yang Hospital
        • Contact:
      • Beijing, Beijing, China, 100020
        • Not yet recruiting
        • China-Japan Friendship Hospital
        • Contact:
      • Beijing, Beijing, China, 100032
        • Not yet recruiting
        • Beijing Friendship Hospital Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100032
        • Not yet recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, Beijing, China, 100039
        • Recruiting
        • General Hospital of Chinese Armed Police Forces
        • Contact:
      • Beijing, Beijing, China, 102200
        • Not yet recruiting
        • Peking University International Hospital
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China
        • Not yet recruiting
        • The first affiliated hospital affiliated to AMU (Southwest Hospital)
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Not yet recruiting
        • The Third Affiliated Hospital of Sun Yat-Sen University
        • Contact:
      • Shenzhen, Guangdong, China, 518000
        • Not yet recruiting
        • the University of Hongkong-Shenzhen Hospital
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
      • Tangshan, Hebei, China, 063000
        • Recruiting
        • Tangshan Gongren Hospital
        • Contact:
    • Heilongjiang
      • Shuangyashan, Heilongjiang, China
        • Recruiting
        • Hong Xinglong Central Hospital
        • Contact:
          • Degang Sun
    • Henan
      • Nanyang, Henan, China
        • Not yet recruiting
        • Nanshi Hospital of Nanyang
        • Contact:
    • Hubei
      • Shiyan, Hubei, China
        • Not yet recruiting
        • Affiliated Taihe Hospital of Hubei University of Medicine
        • Contact:
          • Zhibing Ai
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Tongji Hospital, Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Hengyang, Hunan, China, Hunan
        • Active, not recruiting
        • The First Affiliated Hospital of University of South China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Recruiting
        • Subei People's Hospital of Jiangsu province
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • China-Japan Union Hospital, Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110840
        • Not yet recruiting
        • General Hospital of Shen Yang Millitary Command
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China
        • Recruiting
        • People's Hospital Ningxia Hui Autonomous Region
        • Contact:
          • Zhimin Shi
    • Shandong
      • Jinan, Shandong, China
        • Active, not recruiting
        • Shandong Provincial Hospital
      • Jining, Shandong, China, 272000
        • Recruiting
        • JiNing NO.1 People Hospital
        • Contact:
      • Qingdao, Shandong, China, 266000
        • Not yet recruiting
        • Qingdao Municipal Hospital
        • Contact:
      • Qingdao, Shandong, China, 266555
        • Not yet recruiting
        • Qilu Hospital of Shandong University (QingDao)
        • Contact:
      • Weihai, Shandong, China
        • Not yet recruiting
        • Weihai Municipal Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200050
        • Not yet recruiting
        • Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
      • Shanghai, Shanghai, China, 200050
        • Recruiting
        • Tongren hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
    • Shanxi
      • Changzhi, Shanxi, China
        • Not yet recruiting
        • Changzhi People's Hospital
        • Contact:
          • Lifang Zhang
      • Taiyuan, Shanxi, China
        • Not yet recruiting
        • Taiyuan Central Hospital of Shanxi Meidical University
        • Contact:
          • Weirong Li
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • First Affiliated Hospital of Zhejiang University
        • Contact:
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • Zhejiang Provincial Tongde Hospital
        • Contact:
          • Xiaodong Zou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hospital based population

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intracranial Atherosclerosis
First-ever stroke patients attributed to intracranial artery stenosis (> 50% or occlusion) who receive aggressive medical management
Drug: aggressive medical management
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
Other Names:
  • Aspirin
  • Clopidogrel
  • Rosuvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
poor functional outcome
Time Frame: 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.
90 day after stroke onset
Number of Participants with stroke recurrence
Time Frame: 12 months after stroke onset
stroke recurrence with new lesions on DWI
12 months after stroke onset
Evolution of intracranial atherosclerosis burden
Time Frame: 6 months after stroke onset
Changes of plaque and thrombus volume on HR-MRI images at the admission and the follow-up
6 months after stroke onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Death due to Heart Disease, Cerebravascular Disease or Other Vascular Etiology
Time Frame: 12 months after stroke onset
death due to stroke, intracranial hemorrhage,heart attack,heart failure, arrhythmia,pulmonary embolism,visceral hemorrhage or other vascular etiology
12 months after stroke onset

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events That Are Related to Anti-platelet Treatment
Time Frame: 12 months after stroke onset
intracranial bleeding confirmed by CT，fatal bleeding causing hemodynamic abnormalities needed blood tranfusion or surgical intervention
12 months after stroke onset
Number of Participants with Adverse Events That Are Related to StatinTreatment
Time Frame: 12 months after stroke onset
more than 3-fold liver enzyme increase，rhabdomyolysis
12 months after stroke onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wei-Hai Xu

Collaborators

Peking University First Hospital
General Hospital of Chinese Armed Police Forces
General Hospital of Shenyang Military Region
Beijing Friendship Hospital
Peking Union Medical College Hospital
The Second Hospital of Hebei Medical University
Southwest Hospital, China
West China Hospital
Tongji Hospital
Hebei General Hospital
Peking University International Hospital
Shanghai Tong Ren Hospital
First Affiliated Hospital of Zhejiang University
Shandong Provincial Hospital
Beijing Tongren Hospital
Beijing Chao Yang Hospital
Beijing Hospital
Qingdao Municipal Hospital
Beijing Anzhen Hospital
China-Japan Friendship Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Fujian Medical University Union Hospital
The First Affiliated Hospital of University of South China
China-Japan Union Hospital, Jilin University
Subei People's Hospital of Jiangsu Province
Weihai Municipal Hospital
Zhejiang Provincial Tongde Hospital
Tangshan Gongren Hospital
Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine
JiNing NO.1 People Hospital
The University of HongKong-Shenzhen Hospital
Qilu Hospital of Shandong University (Qingdao)
People's Hospital of Ningxia Hui Autonomous Region
Taiyuan Central Hospital of Shanxi Medical University
Hong Xinglong Central Hospital
Changzhi People's Hospital
Affiliated Taihe Hospital of Hubei University of Medicine
Nanshi Hospital of Nanyang

Investigators

  • Study Chair: Weihai Xu, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 28, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRMRI II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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