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

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ClinicalTrials.gov Identifier: NCT03719820
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : November 15, 2019
Sponsor:
Collaborators:
Peking Union Medical College Hospital
General Hospital of Chinese Armed Police Forces
General Hospital of Shenyang Military Region
Subei People's Hospital of Jiangsu Province
Fujian Medical University Union Hospital
Tangshan Gongren Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Qingdao Municipal Hospital
West China Hospital
Shanghai Tong Ren Hospital
Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine
The First Affiliated Hospital of University of South China
JiNing NO.1 People Hospital
Tongji Hospital
The University of HongKong-Shenzhen Hospital
Beijing Anzhen Hospital
Beijing Hospital
Peking University International Hospital
Beijing Tongren Hospital
China-Japan Friendship Hospital
Peking University First Hospital
Beijing Friendship Hospital
Beijing Chao Yang Hospital
Qilu Hospital of Shandong University (Qingdao)
Shandong Provincial Hospital
The Second Hospital of Hebei Medical University
Hebei General Hospital
First Affiliated Hospital of Zhejiang University
China-Japan Union Hospital, Jilin University
Zhejiang Provincial Tongde Hospital
People's Hospital of Ningxia Hui Autonomous Region
Taiyuan Central Hospital of Shanxi Medical University
Hong Xinglong Central Hospital
Changzhi People's Hospital
Information provided by (Responsible Party):
Wei-Hai Xu, Peking Union Medical College Hospital

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).

Condition or disease Intervention/treatment
Acute Ischemic Stroke AIS Intracranial Atherosclerosis ICAS Drug: aggressive medical management

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Stroke Imaging Package Study of Intracranial Atherosclerosis
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

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




Primary Outcome Measures :
  1. 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.

  2. Number of Participants with stroke recurrence [ Time Frame: 12 months after stroke onset ]
    stroke recurrence with new lesions on DWI

  3. Evolution of intracranial atherosclerosis burden [ Time Frame: 6 months after stroke onset ]
    The disparity in morphological attributes including plaque and thrombus on HR-MRI images


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hospital based population
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719820


Contacts
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Contact: Weihai Xu, MD 010-69156114 xuwh@pumch.cn
Contact: Yining Huang, MD ynhuang@sina.com

  Show 33 Study Locations
Sponsors and Collaborators
Wei-Hai Xu
Peking Union Medical College Hospital
General Hospital of Chinese Armed Police Forces
General Hospital of Shenyang Military Region
Subei People's Hospital of Jiangsu Province
Fujian Medical University Union Hospital
Tangshan Gongren Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Qingdao Municipal Hospital
West China Hospital
Shanghai Tong Ren Hospital
Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine
The First Affiliated Hospital of University of South China
JiNing NO.1 People Hospital
Tongji Hospital
The University of HongKong-Shenzhen Hospital
Beijing Anzhen Hospital
Beijing Hospital
Peking University International Hospital
Beijing Tongren Hospital
China-Japan Friendship Hospital
Peking University First Hospital
Beijing Friendship Hospital
Beijing Chao Yang Hospital
Qilu Hospital of Shandong University (Qingdao)
Shandong Provincial Hospital
The Second Hospital of Hebei Medical University
Hebei General Hospital
First Affiliated Hospital of Zhejiang University
China-Japan Union Hospital, Jilin University
Zhejiang Provincial Tongde Hospital
People's Hospital of Ningxia Hui Autonomous Region
Taiyuan Central Hospital of Shanxi Medical University
Hong Xinglong Central Hospital
Changzhi People's Hospital
Investigators
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Study Chair: Weihai Xu, MD Peking Union Medical College Hospital

Additional Information:

Publications:

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Responsible Party: Wei-Hai Xu, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03719820     History of Changes
Other Study ID Numbers: HRMRI II
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wei-Hai Xu, Peking Union Medical College Hospital:
Acute Ischemic Stroke
Intracranial Atherosclerosis ICAS
HRMRI
Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Stroke
Intracranial Arteriosclerosis
Atherosclerosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Intracranial Arterial Diseases
Rosuvastatin Calcium
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics