Chinese Atherosclerosis Risk Evaluation- Phase II

NCT02017756 | Unknown DMC

• 1 other identifier: Tsinghua-985
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 14

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.

Conditions

Ischemic Stroke; Transient Ischemic Attack; Carotid Atherosclerotic Disease

Keywords

Carotid artery; Atherosclerosis; Vulnerable plaque; Magnetic resonance imaging; Arterial wall

Outcome Measures

Primary Outcomes (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.

  within two weeks after symptom onset

Secondary Outcomes (3)

• Carotid wall and brain infarct measurements.

  within two weeks after symptom onset

• Traditional risk factors.

  within two weeks after symptom onset

• Incidence and volume of carotid plaques and geographic region of subjects.

  within two weeks after symptom onset

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tsinghua University: lead

Study Sites (14)

Department of Radiology, Peking University First Hospital

Beijing, 100034, China

RECRUITING

Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University

Beijing, 100084, China

RECRUITING

Department of Radiology, Beijing Hospital

Beijing, 100730, China

RECRUITING

Department of Radiology, PLA General Hospital

Beijing, 100853, China

RECRUITING

Department of Radiology, Fujian Medical University Union Hospital

Fuzhou, 350001, China

RECRUITING

Department of Radiology, Sun Yat-Sen Memorial Hospital

Guangzhou, 510120, China

RECRUITING

Department of Radiology, Zhujiang Hospital of Southern Medical University

Guangzhou, 510282, China

RECRUITING

Department of Radiology, Harbin University The Fourth Affiliated Hospital

Harbin, 150001, China

RECRUITING

Shandong Medical Imaging Research Institute

Jinan, 250021, China

RECRUITING

Department of Radiology, Nanjing Drum Tower Hospital

Nanjing, 210008, China

RECRUITING

Department of Radiology, The First Hospital of Qiqihaer City

Qiqihar, 161005, China

RECRUITING

Department of Radiology, Shanghai Renji Hospital

Shanghai, 200127, China

RECRUITING

Department of Radiology, Tianjin Fourth Centre Hospital

Tianjin, 300140, China

RECRUITING

Department of Radiology, Qinghai University Affiliated Hospital

Xining, 810001, China

RECRUITING

Related Publications (17)

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  PMID: 22052510 BACKGROUND

• 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.

  PMID: 11062288 BACKGROUND

• 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.

  PMID: 18325441 BACKGROUND

• 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.

  PMID: 3574413 BACKGROUND

• 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.

  PMID: 12221054 BACKGROUND

• 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.

  PMID: 11673345 BACKGROUND

• 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.

  PMID: 15653565 BACKGROUND

• 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 Nov;45(11):2097-2108. doi: 10.1161/ATVBAHA.125.323413. Epub 2025 Sep 18.

  PMID: 40964717 DERIVED

• 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.

  PMID: 38711198 DERIVED

• 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.

  PMID: 36596656 DERIVED

• 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.

  PMID: 34587796 DERIVED

• 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.

  PMID: 33903178 DERIVED

• 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.

  PMID: 32404502 DERIVED

• 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.

  PMID: 31262337 DERIVED

• 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.

  PMID: 30354232 DERIVED

• 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.

  PMID: 28959486 DERIVED

• 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.

  PMID: 28862936 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Carotid Artery Diseases; Atherosclerosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Chun Yuan, PhD

  Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xihai Zhao, MD, PhD

CONTACT

861062792662; xihaizhao@tsinghua.edu.cn

Rui Li, PhD

CONTACT

861062785758; leerui@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 23, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

CN (14)