AzTrials
AzTrials

Acute Ischemic Stroke AISSIPS-ICASNCT03719820

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

An observational study of Acute Ischemic Stroke AIS and Intracranial Atherosclerosis ICAS, run by Wei-Hai Xu at 38 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 35 to 80 years
What is being tested?
aggressive medical management
How many people
550 participants
Where
38 sitesChina
Study dates
14 Nov 2018to 30 Jun 2021
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: hospital based population

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

38 sites in 1 country.

Weihai Xu, MD contact

010-69156114

xuwh@pumch.cn

Yining Huang, MD contact

ynhuang@sina.com

38 sites in 1 country

China38 sites, 36 recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality, 100010

    Tao Gong, 13718907701, gb20598@sina.com

    Recruiting

  • Beijing Tongren Hospital Capital Medical University

    Beijing, Beijing Municipality, 100010

    Jiawei Wang, 18811612263, wangjwcq@1163.com

    Not yet recruiting

  • Beijing Anzhen Hospital Capital Medical University

    Beijing, Beijing Municipality, 100020

    Guangzhi Liu, 13391777952, guangzhi2002@hotmali.com

    Recruiting

  • Beijing Chao-Yang hospital

    Beijing, Beijing Municipality, 100020

    Wenli Hu, 13552983366, huwenli@sina.com

    Not yet recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100020

    Dantao Peng, 13910908579, 18513415053@163.com

    Not yet recruiting

  • Beijing Friendship Hospital Capital Medical University

    Beijing, Beijing Municipality, 100032

    Yongbo Zhang, 13552909549, ybzhangcn@sina.com

    Not yet recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100032

    Yining Huang, 13910432166, ynhuang@sina.com

    Not yet recruiting

  • General Hospital of Chinese Armed Police Forces

    Beijing, Beijing Municipality, 100039

    Shiwen Wu, MD, 13910238117, neurowu@gmail.com

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Weihai Xu, MD, 010-69156372, xuwh@pumch.cn

    Recruiting

  • Peking University International Hospital

    Beijing, Beijing Municipality, 102200

    Xianzeng Liu, 13911879817, liuxianzeng@pkuih.edu.cn

    Not yet recruiting

  • China-Japan Union Hospital, Jilin University

    Changchun, Jilin

    Le Fang, MD, drfangle@sina.com

    Recruiting

  • Changzhi People's Hospital

    Changzhi, Shanxi

    Lifang Zhang

    Not yet recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

    Bo Wu, dr.bowu@hotmail.com

    Recruiting

  • The first affiliated hospital affiliated to AMU (Southwest Hospital)

    Chongqing, Chongqing Municipality

    Zhenhua Zhou, exploiter001@126.com

    Not yet recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Changyun Liu, MD, 13365910778, 13365910778@139.com

    Recruiting

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510630

    Zhengqi Lu, 13570102668, lzq1828@aliyun.com

    Not yet recruiting

  • First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang

    Hui Liang, wen1937@163.com

    Recruiting

  • Zhejiang Provincial Tongde Hospital

    Hangzhou, Zhejiang

    Xiaodong Zou

    Not yet recruiting

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan, Hunan

    Active, not recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong

    Active, not recruiting

  • JiNing NO.1 People Hospital

    Jining, Shandong, 272000

    Zhongrui Yan, 18678769700, zhongruiy@163.com

    Recruiting

  • Nanshi Hospital of Nanyang

    Nanyang, Henan

    Xiaohua Xiao, 2207988910@qq.com

    Not yet recruiting

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266000

    Jintai Yu, yu-jintai@163.com

    Not yet recruiting

  • Qilu Hospital of Shandong University (Qingdao)

    Qingdao, Shandong, 266555

    Haifeng Li, 18561810375, drlhf@163.com

    Not yet recruiting

  • Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200050

    Jun Liu, jly0520@hotmail.com

    Not yet recruiting

  • Tongren Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200050

    Ailian Du, lotusdu@126.com

    Recruiting

  • General Hospital of Shen Yang Millitary Command

    Shenyang, Liaoning, 110840

    Huishen Chen, MD, 13352452086, chszh@aliyun.com

    Not yet recruiting

  • The University of HongKong-Shenzhen Hospital

    Shenzhen, Guangdong, 518000

    Xiaofan Chu, chuxf@hku-szh.org

    Not yet recruiting

  • Hebei General Hospital

    Shijiazhuang, Hebei

    Litao Li, dingding51800@163.com

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Xiaoyun Liu, AUDREY-L@163.com

    Recruiting

  • Affiliated Taihe Hospital of Hubei University of Medicine

    Shiyan, Hubei

    Zhibing Ai

    Not yet recruiting

  • Hong Xinglong Central Hospital

    Shuangyashan, Heilongjiang

    Degang Sun

    Recruiting

  • Taiyuan Central Hospital of Shanxi Meidical University

    Taiyuan, Shanxi

    Weirong Li

    Not yet recruiting

  • Tangshan Gongren Hospital

    Tangshan, Hebei, 063000

    Baoquan Lu, 13930565557, balcom@163.com

    Recruiting

  • Weihai Municipal Hospital

    Weihai, Shandong

    Haixia Zhang, 371704058@qq.com

    Not yet recruiting

  • Tongji Hospital, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Daishi Tian, tiands@foxmail.com

    Recruiting

  • Subei People's Hospital of Jiangsu Province

    Yangzhou, Jiangsu, 225001

    Jun Xu, MD, 18051061768, 13611572068@126.com

    Recruiting

  • People's Hospital Ningxia Hui Autonomous Region

    Yinchuan, Ningxia

    Zhimin Shi

    Recruiting

Other trials in China

About this study

Official title: 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).

Read the 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.
Being tested
aggressive medical management
Keywords
Acute Ischemic Stroke, Intracranial Atherosclerosis ICAS, HRMRI
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aggressive medical managementDrug

    Also called Aspirin, Clopidogrel, Rosuvastatin

    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

Study groups in NCT03719820
Study groupRoleWhat they receive
Intracranial AtherosclerosisFirst-ever stroke patients attributed to intracranial artery stenosis (> 50% or occlusion) who receive aggressive medical management
Receives: Drug: aggressive medical management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. poor functional outcome

    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.

    Measured: 90 day after stroke onset

  2. Number of Participants with stroke recurrence

    stroke recurrence with new lesions on DWI

    Measured: 12 months after stroke onset

  3. Evolution of intracranial atherosclerosis burden

    Changes of plaque and thrombus volume on HR-MRI images at the admission and the follow-up

    Measured: 6 months after stroke onset

Secondary outcomes (1)

  1. Number of Participants with Death due to Heart Disease, Cerebravascular Disease or Other Vascular Etiology

    death due to stroke, intracranial hemorrhage,heart attack,heart failure, arrhythmia,pulmonary embolism,visceral hemorrhage or other vascular etiology

    Measured: 12 months after stroke onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2018
  2. Study start14 Nov 2018
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion30 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
550 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03719820
Sponsor's protocol ID
HRMRI II
Acronym
SIPS-ICAS
Status last verified
Mar 2020
First submitted
22 Oct 2018
Last updated
31 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li ML, Xu WH, Song L, Feng F, You H, Ni J, Gao S, Cui LY, Jin ZY. Atherosclerosis of middle cerebral artery: evaluation with high-resolution MR imaging at 3T. Atherosclerosis. 2009 Jun;204(2):447-52. doi: 10.1016/j.atherosclerosis.2008.10.019. Epub 2008 Oct 25.

    PubMed 19041971

  • Mazighi M, Labreuche J, Gongora-Rivera F, Duyckaerts C, Hauw JJ, Amarenco P. Autopsy prevalence of intracranial atherosclerosis in patients with fatal stroke. Stroke. 2008 Apr;39(4):1142-7. doi: 10.1161/STROKEAHA.107.496513. Epub 2008 Feb 28.

    PubMed 18309170

  • Xu WH, Li ML, Gao S, Ni J, Zhou LX, Yao M, Peng B, Feng F, Jin ZY, Cui LY. In vivo high-resolution MR imaging of symptomatic and asymptomatic middle cerebral artery atherosclerotic stenosis. Atherosclerosis. 2010 Oct;212(2):507-11. doi: 10.1016/j.atherosclerosis.2010.06.035. Epub 2010 Jun 25.

    PubMed 20638663

  • Xu WH, Li ML, Gao S, Ni J, Zhou LX, Yao M, Peng B, Feng F, Jin ZY, Cui LY. Plaque distribution of stenotic middle cerebral artery and its clinical relevance. Stroke. 2011 Oct;42(10):2957-9. doi: 10.1161/STROKEAHA.111.618132. Epub 2011 Jul 28.

    PubMed 21799160

  • Xu WH, Li ML, Gao S, Ni J, Yao M, Zhou LX, Peng B, Feng F, Jin ZY, Cui LY. Middle cerebral artery intraplaque hemorrhage: prevalence and clinical relevance. Ann Neurol. 2012 Feb;71(2):195-8. doi: 10.1002/ana.22626.

    PubMed 22367991

  • Xu WH, Li ML, Niu JW, Feng F, Jin ZY, Gao S. Intracranial artery atherosclerosis and lumen dilation in cerebral small-vessel diseases: a high-resolution MRI Study. CNS Neurosci Ther. 2014 Apr;20(4):364-7. doi: 10.1111/cns.12224. Epub 2014 Jan 15.

    PubMed 24423003

  • Xu WH, Li ML, Niu JW, Feng F, Jin ZY, Gao S. Deep tiny flow voids along middle cerebral artery atherosclerotic occlusions: a high-resolution MR imaging study. J Neurol Sci. 2014 Apr 15;339(1-2):130-3. doi: 10.1016/j.jns.2014.01.042. Epub 2014 Feb 6.

    PubMed 24530171

  • Li M, Wu SW, Xu WH. High-resolution MRI of radiation-induced intracranial vasculopathy. Neurology. 2015 Feb 10;84(6):631. doi: 10.1212/WNL.0000000000001223. No abstract available.

    PubMed 25666631

  • Derdeyn CP, Chimowitz MI, Lynn MJ, Fiorella D, Turan TN, Janis LS, Montgomery J, Nizam A, Lane BF, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Lynch JR, Zaidat OO, Rumboldt Z, Cloft HJ; Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial Investigators. Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial. Lancet. 2014 Jan 25;383(9914):333-41. doi: 10.1016/S0140-6736(13)62038-3. Epub 2013 Oct 26.

    PubMed 24168957

  • Xu YY, Li ML, Gao S, Hou B, Sun ZY, Zhou HL, Feng F, Xu WH. Non-moyamoya vessel network formation along steno-occlusive middle cerebral artery. Neurology. 2016 May 24;86(21):1957-63. doi: 10.1212/WNL.0000000000002698. Epub 2016 Apr 27.

    PubMed 27164677

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Ischemic Stroke AIS and Intracranial Atherosclerosis ICAS, run by Wei-Hai Xu at 38 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Weihai Xu, MD (010-69156114, xuwh@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

poor functional outcome (time frame: 90 day after stroke onset). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03719820, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in