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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
  1. Xihai Zhao1,
  2. Rui Li1,
  3. Daniel S Hippe2,
  4. Thomas S Hatsukami3,
  5. Chun Yuan1,2,
  6. CARE-II Investigators
  1. 1Department of Biomedical Engineering, Center for Biomedical Imaging Research, Tsinghua University School of Medicine, Beijing, China
  2. 2Department of Radiology, University of Washington, Seattle, Washington, USA
  3. 3Department of Surgery, University of Washington, Seattle, Washington, USA
  1. Correspondence to Dr Rui Li; leerui{at}tsinghua.edu.cn

Abstract

Background Carotid atherosclerotic plaque is identified as one of the main sources of ischaemic stroke. However, the prevalence of carotid high-risk atherosclerotic plaque in Chinese patients with ischaemic cerebrovascular events has been inconsistently reported and needs to be investigated in a large population.

Objectives The primary objective of CARE II study was to determine the prevalence and characteristics of high-risk features of atherosclerotic plaques in the carotid arteries in Chinese patients with recent ischaemic stroke or transient ischaemia attack (TIA). The relationship between carotid plaque features and cerebral infarcts, the differences of carotid plaque patterns among different regions of China and the gender specific characteristics of carotid plaque will be also determined.

Study design The CARE II study will enrol 1000 patients with recent ischaemic stroke or TIA and carotid plaque from 13 hospitals and medical centres across China. In this cross-sectional, non-randomised, observational, multicentre study, all patients will undergo carotid artery MRI of bilateral carotid arteries and routine brain MRI with standardised protocols. The MRI will be interpreted at core reading centres to evaluate the characteristics of morphology and compositions of carotid plaque.

Conclusions This is a cross-sectional, multicentre study to investigate the prevalence and characteristics of high-risk atherosclerotic carotid plaque in Chinese patients with stroke and TIA by using high-resolution MRI of vessel wall. This trial is sufficiently powered to demonstrate the prevalence of carotid high-risk plaque and to explore regional differences in Chinese patients who suffered stroke.

Trial registration number NCT02017756.

  • Atherosclerosis
  • Plaque
  • Stenosis
  • Vessel Wall
  • MRI

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors XZ and CY conceived this study. RL provided technical supports. DSH conducted statistical analysis. XZ interpreted the data. XZ and DSH drafted this manuscript and CY and TSH made critical revisions. CY supervised this study.

  • Funding This study is supported by grants of Natural Science Foundation of China (81271536, 61271132 and 81361120402) and Philips Healthcare.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval The Institutional review Board of Tsinghua University School of Medicine.

  • Provenance and peer review Not commissioned; externally peer reviewed.