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

NCT03719820 | Unknown

• 1 other identifier: HRMRI II
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 38

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).

Conditions

Acute Ischemic Stroke AIS; Intracranial Atherosclerosis ICAS

Keywords

Acute Ischemic Stroke; Intracranial Atherosclerosis ICAS; HRMRI

Outcome Measures

Primary Outcomes (3)

• 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.

  90 day after stroke onset

• Number of Participants with stroke recurrence

  stroke recurrence with new lesions on DWI

  12 months after stroke onset

• Evolution of intracranial atherosclerosis burden

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

  6 months after stroke onset

Secondary Outcomes (1)

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

  12 months after stroke onset

Other Outcomes (2)

• Number of Participants with Adverse Events That Are Related to Anti-platelet Treatment

  12 months after stroke onset

• Number of Participants with Adverse Events That Are Related to StatinTreatment

  12 months after stroke onset

Study Arms (1)

Intracranial Atherosclerosis

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

Drug: aggressive medical management

Interventions

aggressive medical management DRUG

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

Also known as: Aspirin, Clopidogrel, Rosuvastatin

Intracranial Atherosclerosis

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospital based population

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (38)

Beijing Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

Beijing Tongren Hospital Capital Medical University

Beijing, Beijing Municipality, 100010, China

NOT YET RECRUITING

Beijing Anzhen Hospital Capital Medical University

Beijing, Beijing Municipality, 100020, China

RECRUITING

Beijing Chao-Yang hospital

Beijing, Beijing Municipality, 100020, China

NOT YET RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100020, China

NOT YET RECRUITING

Beijing Friendship Hospital Capital Medical University

Beijing, Beijing Municipality, 100032, China

NOT YET RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100032, China

NOT YET RECRUITING

General Hospital of Chinese Armed Police Forces

Beijing, Beijing Municipality, 100039, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Peking University International Hospital

Beijing, Beijing Municipality, 102200, China

NOT YET RECRUITING

The first affiliated hospital affiliated to AMU (Southwest Hospital)

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

NOT YET RECRUITING

The University of HongKong-Shenzhen Hospital

Shenzhen, Guangdong, 518000, China

NOT YET RECRUITING

Hebei General Hospital

Shijiazhuang, Hebei, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Tangshan Gongren Hospital

Tangshan, Hebei, 063000, China

RECRUITING

Hong Xinglong Central Hospital

Shuangyashan, Heilongjiang, China

RECRUITING

Nanshi Hospital of Nanyang

Nanyang, Henan, China

NOT YET RECRUITING

Affiliated Taihe Hospital of Hubei University of Medicine

Shiyan, Hubei, China

NOT YET RECRUITING

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

The First Affiliated Hospital of University of South China

Hengyang, Hunan, Hunan, China

ACTIVE NOT RECRUITING

Subei People's Hospital of Jiangsu Province

Yangzhou, Jiangsu, 225001, China

RECRUITING

China-Japan Union Hospital, Jilin University

Changchun, Jilin, China

RECRUITING

General Hospital of Shen Yang Millitary Command

Shenyang, Liaoning, 110840, China

NOT YET RECRUITING

People's Hospital Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China

RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

ACTIVE NOT RECRUITING

JiNing NO.1 People Hospital

Jining, Shandong, 272000, China

RECRUITING

Qingdao Municipal Hospital

Qingdao, Shandong, 266000, China

NOT YET RECRUITING

Qilu Hospital of Shandong University (Qingdao)

Qingdao, Shandong, 266555, China

NOT YET RECRUITING

Weihai Municipal Hospital

Weihai, Shandong, China

NOT YET RECRUITING

Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200050, China

NOT YET RECRUITING

Tongren Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200050, China

RECRUITING

Changzhi People's Hospital

Changzhi, Shanxi, China

NOT YET RECRUITING

Taiyuan Central Hospital of Shanxi Meidical University

Taiyuan, Shanxi, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Zhejiang Provincial Tongde Hospital

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Related Publications (10)

• 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.

  PMID: 19041971 BACKGROUND

• 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.

  PMID: 18309170 BACKGROUND

• 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.

  PMID: 20638663 BACKGROUND

• 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.

  PMID: 21799160 BACKGROUND

• 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.

  PMID: 22367991 BACKGROUND

• 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.

  PMID: 24423003 BACKGROUND

• 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.

  PMID: 24530171 BACKGROUND

• 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.

  PMID: 25666631 BACKGROUND

• 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.

  PMID: 24168957 BACKGROUND

• 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.

  PMID: 27164677 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin; Clopidogrel; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Pyrimidines

Study Officials

• Weihai Xu, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Weihai Xu, MD

CONTACT

010-69156114; xuwh@pumch.cn

Yining Huang, MD

CONTACT

ynhuang@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 25, 2018
• Study Start: November 14, 2018
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

CN (38)