CARE-II: Chinese Atherosclerosis Risk Evaluation- Phase II

Sponsor

Tsinghua University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02017756

Collaborator

(none)

1,000

Enrollment

Locations

Duration (Months)

71.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke Transient Ischemic Attack Carotid Atherosclerotic Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

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 :

Jan 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Carotid wall and brain infarct measurements. [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. [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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Radiology, Peking University First Hospital	Beijing	China	100034
2	Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University	Beijing	China	100084
3	Department of Radiology, Beijing Hospital	Beijing	China	100730
4	Department of Radiology, PLA General Hospital	Beijing	China	100853
5	Department of Radiology, Fujian Medical University Union Hospital	Fuzhou	China	350001
6	Department of Radiology, Sun Yat-Sen Memorial Hospital	Guangzhou	China	510120
7	Department of Radiology, Zhujiang Hospital of Southern Medical University	Guangzhou	China	510282
8	Department of Radiology, Harbin University The Fourth Affiliated Hospital	Harbin	China	150001
9	Shandong Medical Imaging Research Institute	Jinan	China	250021
10	Department of Radiology, Nanjing Drum Tower Hospital	Nanjing	China	210008
11	Department of Radiology, The First Hospital of Qiqihaer City	Qiqihar	China	161005
12	Department of Radiology, Shanghai Renji Hospital	Shanghai	China	200127
13	Department of Radiology, Tianjin Fourth Centre Hospital	Tianjin	China	300140
14	Department of Radiology, Qinghai University Affiliated Hospital	Xining	China	810001