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Chinese Atherosclerosis Risk Evaluation- Phase II (CARE-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02017756
Recruitment Status : Unknown
Verified December 2013 by Chun Yuan, Tsinghua University.
Recruitment status was:  Recruiting
First Posted : December 23, 2013
Last Update Posted : December 23, 2013
Information provided by (Responsible Party):
Chun Yuan, Tsinghua University

Brief Summary:

Stroke is the first and the fourth leading cause of death in the United States and China, respectively. Disruption of cerebrovascular vulnerable atherosclerotic plaque is the major etiology of ischemic stroke. Therefore, early detection and treatment of vulnerable plaques occurring at the feeding arteries to brain (cerebral arteries) will be helpful for prevention of stroke.

Atherosclerosis is a systemic disease that usually affects multiple vascular beds. Previous studies have shown that these high risk lesions in different segments of cerebral arteries (intracranial and extracranial arteries) might be racially specific. It is reported that, in stroke patients, intracranial vulnerable plaques are prevalent in Asian populations whereas atherosclerosis more frequently involves extracranial carotid arteries in American subjects. However, these findings are based on angiographic imaging approaches via measuring arterial luminal stenosis. Because the atherosclerotic plaque often appears as outward expansion, namely positive remodeling during progression, measuring luminal stenosis will underestimate the disease severity. Hence, directly viewing the plaque in the vessel wall is strongly suggested in order to objectively evaluate the cerebrovascular vulnerable plaque.

High resolution, black-blood magnetic resonance (MR) imaging has been widely used to accurately characterize carotid vulnerable plaque in the last two decades. The aim of using MR black-blood techniques is to suppress the blood signal (black) to enhance the signal contrast between the vessel wall and blood in the arterial lumen. Excellent agreement has been achieved between MR imaging and histology in identification of plaque components, such as intraplaque hemorrhage and lipid core. For assessing carotid plaque, MR imaging is superior to computed tomography and ultrasound imaging techniques due to its advantages including noninvasive imaging, lack of ionizing radiation, excellent soft tissue resolution, and multi-parametric image acquisition.

The Investigators hypothesize that there are specific characteristics in carotid vulnerable plaques in Chinese patients with ischemic cerebrovascular events such as ischemic stroke and transient ischemic attack (TIA). This study seeks to investigate the characteristics of vulnerable plaque in carotid arteries using high resolution, black-blood MR imaging in patients with recent TIA or ischemic stroke.

This is a cross-sectional, multicenter study. A total of 1000 patients will be recruited from more than 10 different hospitals across China within 3 years. All patients will undergo MR imaging for brain and carotid arteries within two weeks after symptom onset. The prevalence of carotid vulnerable plaque and its correlations with brain ischemic lesions, traditional risk factors, and regional distribution of China will be determined.

Condition or disease
Ischemic Stroke Transient Ischemic Attack Carotid Atherosclerotic Disease

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Phase II Study of Chinese Atherosclerosis Risk Evaluation: Investigation of Carotid Atherosclerotic Disease in Patients With Ischemic Cerebrovascular Events
Study Start Date : January 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Primary Outcome Measures :
  1. Prevalence of carotid vulnerable plaques, defined as lesions with intraplaque hemorrhage, fibrous cap rupture, or lipid core occupying >40% of vessel wall area as determined by high resolution, black-blood MR imaging in this study population. [ Time Frame: within two weeks after symptom onset ]

Secondary Outcome Measures :
  1. Carotid wall and brain infarct measurements. [ Time Frame: within two weeks after symptom onset ]

    The following features will be measured: carotid mean wall thickness, normalized wall index, and incidence of compositional features (calcification, lipid core, intraplaque hemorrhage, cap rupture) and volume of cerebral white matter lesions or infarcts.

    These measurements will be used to determine the relationship of carotid wall features with the volume of cerebral white matter lesions or infarcts.

  2. Traditional risk factors. [ Time Frame: within two weeks after symptom onset ]
    Traditional risk factors will be collected from subjects including: age, gender, hypertension, smoke, diabetes, and history of cardiovascular disease. The association of the volume and incidence of carotid plaque calcification, lipid core, and intraplaque hemorrhage with traditional risk factors will be evaluated.

  3. Incidence and volume of carotid plaques and geographic region of subjects. [ Time Frame: within two weeks after symptom onset ]
    The incidence and the volume of carotid plaque calcification, lipid core, and intraplaque hemorrhage will be measured and collected. Data on geographic region of subjects in China, such as Northeast, North, East, South, and Western areas will be collected. This data will be used to study compare incidence and volume of carotid plaque features with geographic regions of subjects.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In this study, we plan to recruit patients with recent TIA of ischemic stroke (within 2 weeks) and carotid atherosclerotic plaque determined by ultrasound. The patients will be recruited from more than 10 hospitals in different areas of China.

Inclusion Criteria:

  • Patients with recent TIA of ischemic stroke (2 weeks) and carotid plaque determined by ultrasound will be included in this study.

Exclusion Criteria:

  • Patients with contraindications to MR scan
  • Patients with hemorrhagic stroke
  • Patients with evidence of cardiogenic stroke
  • Patients with brain tumors
  • Patients underwent carotid revascularization therapy, such as stenting and endarterectomy

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): NCT02017756

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Contact: Xihai Zhao, MD, PhD 861062792662 xihaizhao@tsinghua.edu.cn
Contact: Rui Li, PhD 861062785758 leerui@gmail.com

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Department of Radiology, Peking University First Hospital Recruiting
Beijing, China, 100034
Contact: Feiyu Li, MD, PhD    8613552292893    redwindowlfy@163.com   
Principal Investigator: Xiaoying Wang, MD, PhD         
Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University Recruiting
Beijing, China, 100084
Contact: Le He, MD    861062796175    hele0806@aliyun.com   
Principal Investigator: Xihai Zhao, MD, PhD         
Department of Radiology, Beijing Hospital Recruiting
Beijing, China, 100730
Contact: Yan Song, MD, PhD    8618610566272    songyan@u.washington.edu   
Principal Investigator: Min Chen, MD, PhD         
Department of Radiology, PLA General Hospital Recruiting
Beijing, China, 100853
Contact: Xu Han, MD    8613810139203    hxlryt@126.com   
Principal Investigator: Jianming Cai, MD, PhD         
Department of Radiology, Fujian Medical University Union Hospital Recruiting
Fuzhou, China, 350001
Contact: Yunjing Xue, MD, PhD    8613950497808    xueyunjing@126.com   
Principal Investigator: Qing Duan, MD         
Department of Radiology, Sun Yat-Sen Memorial Hospital Recruiting
Guangzhou, China, 510120
Contact: Mingwei Xie, MD    15018722452    553614809@qq.com   
Principal Investigator: Biling Liang, MD         
Department of Radiology, Zhujiang Hospital of Southern Medical University Recruiting
Guangzhou, China, 510282
Contact: Jing Zhang, MD    8615521118683    zzjing881205@163.com   
Principal Investigator: Zhibo Wen, MD         
Department of Radiology, Harbin University The Fourth Affiliated Hospital Recruiting
Harbin, China, 150001
Contact: Yang Ji, MD    8613654557419    jiyang19871104@126.com   
Principal Investigator: Dan Wang, MD         
Shandong Medical Imaging Research Institute Recruiting
Jinan, China, 250021
Contact: Honglu Shi, MD    15053177828    shlkb08@163.com   
Principal Investigator: Guangbin Wang, MD, PhD         
Department of Radiology, Nanjing Drum Tower Hospital Recruiting
Nanjing, China, 210008
Contact: Maoxue Wang, MD    8615851803070    fmriwangmx@126.com   
Principal Investigator: Bing Zhang, MD, PhD         
Department of Radiology, The First Hospital of Qiqihaer City Recruiting
Qiqihar, China, 161005
Contact: Zhong Zhuang, MD    8618245281102    zz_15880732@126.com   
Principal Investigator: Xiaogang Peng, MD         
Department of Radiology, Shanghai Renji Hospital Recruiting
Shanghai, China, 200127
Contact: Huilin Zhao, MD    8613918666437    huilinzhao2013@163.com   
Principal Investigator: Jianrong Xu, MD, PhD         
Department of Radiology, Tianjin Fourth Centre Hospital Recruiting
Tianjin, China, 300140
Contact: Xiao Gao, MD    13920924729    03092901010@163.com   
Principal Investigator: Shengzhang Ji, MD         
Department of Radiology, Qinghai University Affiliated Hospital Recruiting
Xining, China, 810001
Contact: Yuntai Cao, MD    8615003666895    caoyuntai04@126.com   
Principal Investigator: Haihua Bao, MD         
Sponsors and Collaborators
Tsinghua University
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Principal Investigator: Chun Yuan, PhD Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chun Yuan, Professor, Tsinghua University
ClinicalTrials.gov Identifier: NCT02017756    
Other Study ID Numbers: Tsinghua-985
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: December 2013
Keywords provided by Chun Yuan, Tsinghua University:
Carotid artery
Vulnerable plaque
Magnetic resonance imaging
Arterial wall
Additional relevant MeSH terms:
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Ischemic Stroke
Ischemic Attack, Transient
Carotid Artery Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Brain Ischemia