Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2012-01-31
2014-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with hemorrhagic stroke
* Patients with evidence of cardiogenic stroke
* Patients with brain tumors
* Patients underwent carotid revascularization therapy, such as stenting and endarterectomy
18 Years
85 Years
ALL
No
Sponsors
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Tsinghua University
OTHER
Responsible Party
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Chun Yuan
Professor
Principal Investigators
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Chun Yuan, PhD
Role: PRINCIPAL_INVESTIGATOR
Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
Locations
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Department of Radiology, Peking University First Hospital
Beijing, , China
Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
Beijing, , China
Department of Radiology, Beijing Hospital
Beijing, , China
Department of Radiology, PLA General Hospital
Beijing, , China
Department of Radiology, Fujian Medical University Union Hospital
Fuzhou, , China
Department of Radiology, Sun Yat-Sen Memorial Hospital
Guangzhou, , China
Department of Radiology, Zhujiang Hospital of Southern Medical University
Guangzhou, , China
Department of Radiology, Harbin University The Fourth Affiliated Hospital
Harbin, , China
Shandong Medical Imaging Research Institute
Jinan, , China
Department of Radiology, Nanjing Drum Tower Hospital
Nanjing, , China
Department of Radiology, The First Hospital of Qiqihaer City
Qiqihar, , China
Department of Radiology, Shanghai Renji Hospital
Shanghai, , China
Department of Radiology, Tianjin Fourth Centre Hospital
Tianjin, , China
Department of Radiology, Qinghai University Affiliated Hospital
Xining, , China
Countries
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Central Contacts
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Facility Contacts
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Feiyu Li, MD, PhD
Role: primary
Le He, MD
Role: primary
Yan Song, MD, PhD
Role: primary
Xu Han, MD
Role: primary
Yunjing Xue, MD, PhD
Role: primary
Mingwei Xie, MD
Role: primary
Jing Zhang, MD
Role: primary
Yang Ji, MD
Role: primary
Honglu Shi, MD
Role: primary
Maoxue Wang, MD
Role: primary
Zhong Zhuang, MD
Role: primary
Huilin Zhao, MD
Role: primary
Xiao Gao, MD
Role: primary
Yuntai Cao, MD
Role: primary
References
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Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011 Dec;42(12):3651-4. doi: 10.1161/STROKEAHA.111.635755. Epub 2011 Nov 3.
Wong KS, Li H, Chan YL, Ahuja A, Lam WW, Wong A, Kay R. Use of transcranial Doppler ultrasound to predict outcome in patients with intracranial large-artery occlusive disease. Stroke. 2000 Nov;31(11):2641-7. doi: 10.1161/01.str.31.11.2641.
Saam T, Underhill HR, Chu B, Takaya N, Cai J, Polissar NL, Yuan C, Hatsukami TS. Prevalence of American Heart Association type VI carotid atherosclerotic lesions identified by magnetic resonance imaging for different levels of stenosis as measured by duplex ultrasound. J Am Coll Cardiol. 2008 Mar 11;51(10):1014-21. doi: 10.1016/j.jacc.2007.10.054.
Glagov S, Weisenberg E, Zarins CK, Stankunavicius R, Kolettis GJ. Compensatory enlargement of human atherosclerotic coronary arteries. N Engl J Med. 1987 May 28;316(22):1371-5. doi: 10.1056/NEJM198705283162204.
Cai JM, Hatsukami TS, Ferguson MS, Small R, Polissar NL, Yuan C. Classification of human carotid atherosclerotic lesions with in vivo multicontrast magnetic resonance imaging. Circulation. 2002 Sep 10;106(11):1368-73. doi: 10.1161/01.cir.0000028591.44554.f9.
Yuan C, Mitsumori LM, Ferguson MS, Polissar NL, Echelard D, Ortiz G, Small R, Davies JW, Kerwin WS, Hatsukami TS. In vivo accuracy of multispectral magnetic resonance imaging for identifying lipid-rich necrotic cores and intraplaque hemorrhage in advanced human carotid plaques. Circulation. 2001 Oct 23;104(17):2051-6. doi: 10.1161/hc4201.097839.
Saam T, Cai JM, Cai YQ, An NY, Kampschulte A, Xu D, Kerwin WS, Takaya N, Polissar NL, Hatsukami TS, Yuan C. Carotid plaque composition differs between ethno-racial groups: an MRI pilot study comparing mainland Chinese and American Caucasian patients. Arterioscler Thromb Vasc Biol. 2005 Mar;25(3):611-6. doi: 10.1161/01.ATV.0000155965.54679.79. Epub 2005 Jan 13.
Shao S, Sun Y, Shi H, Li R, Sun Q, Yao B, Watase H, Hippe DS, Yuan C, Wang G, Zhang Q, Zhao X; Investigators of CARE-II Study. Metabolically Abnormal Obesity and Carotid Plaque Vulnerability: A Vessel Wall MRI Study Linking Obesity Phenotypes to Atherosclerotic Instability. Arterioscler Thromb Vasc Biol. 2025 Sep 18. doi: 10.1161/ATVBAHA.125.323413. Online ahead of print.
Meddings Z, Rundo L, Sadat U, Zhao X, Teng Z, Graves MJ. Robustness and classification capabilities of MRI radiomic features in identifying carotid plaque vulnerability. Br J Radiol. 2024 May 29;97(1158):1118-1124. doi: 10.1093/bjr/tqae057.
Shao S, Shi H, Wang G, Li R, Sun Q, Yao B, Watase H, Hippe DS, Yuan C, Zhao X; Investigators of CARE-II study. Differences in left and right carotid plaque vulnerability in patients with bilateral carotid plaques: a CARE-II study. Stroke Vasc Neurol. 2023 Aug;8(4):284-291. doi: 10.1136/svn-2022-001937. Epub 2023 Jan 3.
Baylam Geleri D, Watase H, Chu B, Chen L, Zhao H, Zhao X, Hatsukami TS, Yuan C; CARE-II Study Collaborators. Detection of Advanced Lesions of Atherosclerosis in Carotid Arteries Using 3-Dimensional Motion-Sensitized Driven-Equilibrium Prepared Rapid Gradient Echo (3D-MERGE) Magnetic Resonance Imaging as a Screening Tool. Stroke. 2022 Jan;53(1):194-200. doi: 10.1161/STROKEAHA.120.032505. Epub 2021 Sep 30.
Jiang C, Zhang J, Zhu J, Wang X, Wen Z, Zhao X, Yuan C; CARE-II Investigators. Association between coexisting intracranial artery and extracranial carotid artery atherosclerotic diseases and ipsilateral cerebral infarction: a Chinese Atherosclerosis Risk Evaluation (CARE-II) study. Stroke Vasc Neurol. 2021 Dec;6(4):595-602. doi: 10.1136/svn-2020-000538. Epub 2021 Apr 26.
Yang D, Ji Y, Wang D, Watase H, Hippe DS, Zhao X, Yuan C. Comparison of carotid atherosclerotic plaques between subjects in Northern and Southern China: a Chinese atherosclerosis risk evaluation study. Stroke Vasc Neurol. 2020 Jun;5(2):138-145. doi: 10.1136/svn-2019-000288. Epub 2020 Jan 29.
Liu Y, Wang M, Zhang B, Wang W, Xu Y, Han Y, Yuan C, Zhao X. Size of carotid artery intraplaque hemorrhage and acute ischemic stroke: a cardiovascular magnetic resonance Chinese atherosclerosis risk evaluation study. J Cardiovasc Magn Reson. 2019 Jul 1;21(1):36. doi: 10.1186/s12968-019-0548-1.
Zhou C, Yuan C, Li R, Wang W, Li C, Zhao X; CARE-II Study Collaborators. Association Between Incomplete Circle of Willis and Carotid Vulnerable Atherosclerotic Plaques. Arterioscler Thromb Vasc Biol. 2018 Nov;38(11):2744-2749. doi: 10.1161/ATVBAHA.118.311797.
Zhao X, Li R, Hippe DS, Hatsukami TS, Yuan C; CARE-II Investigators. Chinese Atherosclerosis Risk Evaluation (CARE II) study: a novel cross-sectional, multicentre study of the prevalence of high-risk atherosclerotic carotid plaque in Chinese patients with ischaemic cerebrovascular events-design and rationale. Stroke Vasc Neurol. 2017 Feb 24;2(1):15-20. doi: 10.1136/svn-2016-000053. eCollection 2017 Mar.
Zhao X, Hippe DS, Li R, Canton GM, Sui B, Song Y, Li F, Xue Y, Sun J, Yamada K, Hatsukami TS, Xu D, Wang M, Yuan C; CARE-II Study Collaborators. Prevalence and Characteristics of Carotid Artery High-Risk Atherosclerotic Plaques in Chinese Patients With Cerebrovascular Symptoms: A Chinese Atherosclerosis Risk Evaluation II Study. J Am Heart Assoc. 2017 Aug 14;6(8):e005831. doi: 10.1161/JAHA.117.005831.
Other Identifiers
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Tsinghua-985
Identifier Type: -
Identifier Source: org_study_id