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

December 16, 2013 updated by: Chun Yuan, Tsinghua University

A Phase II Study of Chinese Atherosclerosis Risk Evaluation: Investigation of Carotid Atherosclerotic Disease in Patients With Ischemic Cerebrovascular Events

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100084
        • Recruiting
        • Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
        • Contact:
        • Principal Investigator:
          • Xihai Zhao, MD, PhD
      • Beijing, China, 100034
        • Recruiting
        • Department of Radiology, Peking University First Hospital
        • Contact:
        • Principal Investigator:
          • Xiaoying Wang, MD, PhD
      • Beijing, China, 100730
        • Recruiting
        • Department of Radiology, Beijing Hospital
        • Contact:
        • Principal Investigator:
          • Min Chen, MD, PhD
      • Beijing, China, 100853
        • Recruiting
        • Department of Radiology, PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Jianming Cai, MD, PhD
      • Fuzhou, China, 350001
        • Recruiting
        • Department of Radiology, Fujian Medical University Union Hospital
        • Contact:
        • Principal Investigator:
          • Qing Duan, MD
      • Guangzhou, China, 510120
        • Recruiting
        • Department of Radiology, Sun Yat-Sen Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Biling Liang, MD
      • Guangzhou, China, 510282
        • Recruiting
        • Department of Radiology, Zhujiang Hospital of Southern Medical University
        • Contact:
        • Principal Investigator:
          • Zhibo Wen, MD
      • Harbin, China, 150001
        • Recruiting
        • Department of Radiology, Harbin University The Fourth Affiliated Hospital
        • Contact:
        • Principal Investigator:
          • Dan Wang, MD
      • Jinan, China, 250021
        • Recruiting
        • Shandong Medical Imaging Research Institute
        • Contact:
        • Principal Investigator:
          • Guangbin Wang, MD, PhD
      • Nanjing, China, 210008
        • Recruiting
        • Department of Radiology, Nanjing Drum Tower Hospital
        • Principal Investigator:
          • Bing Zhang, MD, PhD
        • Contact:
      • Qiqihar, China, 161005
        • Recruiting
        • Department of Radiology, The First Hospital of Qiqihaer City
        • Contact:
        • Principal Investigator:
          • Xiaogang Peng, MD
      • Shanghai, China, 200127
        • Recruiting
        • Department of Radiology, Shanghai Renji Hospital
        • Contact:
        • Principal Investigator:
          • Jianrong Xu, MD, PhD
      • Tianjin, China, 300140
        • Recruiting
        • Department of Radiology, Tianjin Fourth Centre Hospital
        • Contact:
        • Principal Investigator:
          • Shengzhang Ji, MD
      • Xining, China, 810001
        • Recruiting
        • Department of Radiology, Qinghai University Affiliated Hospital
        • Contact:
        • Principal Investigator:
          • Haihua Bao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within two weeks after symptom onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within two weeks after symptom onset
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.
within two weeks after symptom onset
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.
within two weeks after symptom onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tsinghua University

Investigators

  • Principal Investigator: Chun Yuan, PhD, Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

December 4, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Estimate)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 16, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tsinghua-985

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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