Chinese Atherosclerosis Risk Evaluation- Phase II (CARE-II)
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|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
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|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
- 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 ]
- 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.
- 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.
- 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.
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
|Contact: Xihai Zhao, MD, PhDfirstname.lastname@example.org|
|Contact: Rui Li, PhDemail@example.com|
|Department of Radiology, Peking University First Hospital||Recruiting|
|Beijing, China, 100034|
|Contact: Feiyu Li, MD, PhD 8613552292893 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Xihai Zhao, MD, PhD|
|Department of Radiology, Beijing Hospital||Recruiting|
|Beijing, China, 100730|
|Contact: Yan Song, MD, PhD 8618610566272 firstname.lastname@example.org|
|Principal Investigator: Min Chen, MD, PhD|
|Department of Radiology, PLA General Hospital||Recruiting|
|Beijing, China, 100853|
|Contact: Xu Han, MD 8613810139203 email@example.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 firstname.lastname@example.org|
|Principal Investigator: Qing Duan, MD|
|Department of Radiology, Sun Yat-Sen Memorial Hospital||Recruiting|
|Guangzhou, China, 510120|
|Contact: Mingwei Xie, MD 15018722452 email@example.com|
|Principal Investigator: Biling Liang, MD|
|Department of Radiology, Zhujiang Hospital of Southern Medical University||Recruiting|
|Guangzhou, China, 510282|
|Contact: Jing Zhang, MD 8615521118683 firstname.lastname@example.org|
|Principal Investigator: Zhibo Wen, MD|
|Department of Radiology, Harbin University The Fourth Affiliated Hospital||Recruiting|
|Harbin, China, 150001|
|Contact: Yang Ji, MD 8613654557419 email@example.com|
|Principal Investigator: Dan Wang, MD|
|Shandong Medical Imaging Research Institute||Recruiting|
|Jinan, China, 250021|
|Contact: Honglu Shi, MD 15053177828 firstname.lastname@example.org|
|Principal Investigator: Guangbin Wang, MD, PhD|
|Department of Radiology, Nanjing Drum Tower Hospital||Recruiting|
|Nanjing, China, 210008|
|Contact: Maoxue Wang, MD 8615851803070 email@example.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 firstname.lastname@example.org|
|Principal Investigator: Xiaogang Peng, MD|
|Department of Radiology, Shanghai Renji Hospital||Recruiting|
|Shanghai, China, 200127|
|Contact: Huilin Zhao, MD 8613918666437 email@example.com|
|Principal Investigator: Jianrong Xu, MD, PhD|
|Department of Radiology, Tianjin Fourth Centre Hospital||Recruiting|
|Tianjin, China, 300140|
|Contact: Xiao Gao, MD 13920924729 firstname.lastname@example.org|
|Principal Investigator: Shengzhang Ji, MD|
|Department of Radiology, Qinghai University Affiliated Hospital||Recruiting|
|Xining, China, 810001|
|Contact: Yuntai Cao, MD 8615003666895 email@example.com|
|Principal Investigator: Haihua Bao, MD|
|Principal Investigator:||Chun Yuan, PhD||Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University|