Clinical trial NCT02017756: Chinese Atherosclerosis Risk Evaluation- Phase II
Official title: A Phase II Study of Chinese Atherosclerosis Risk Evaluation: Investigation of Carotid Atherosclerotic Disease in Patients With Ischemic Cerebrovascular Events
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Transient Ischemic Attack
Carotid Atherosclerotic Disease
Keywords: Carotid artery
Atherosclerosis
Vulnerable plaque
Magnetic resonance imaging
Arterial wall
Lead sponsor: Tsinghua University
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: within two weeks after symptom onset
Secondary outcomes:
measure: Carotid wall and brain infarct measurements.
timeFrame: within two weeks after symptom onset
measure: Traditional risk factors.
timeFrame: within two weeks after symptom onset
measure: Incidence and volume of carotid plaques and geographic region of subjects.
timeFrame: within two weeks after symptom onset
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiology, Peking University First Hospital
city: Beijing
country: China
facility: Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
city: Beijing
country: China
facility: Department of Radiology, Beijing Hospital
city: Beijing
country: China
facility: Department of Radiology, PLA General Hospital
city: Fuzhou
country: China
facility: Department of Radiology, Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Department of Radiology, Sun Yat-Sen Memorial Hospital
city: Guangzhou
country: China
facility: Department of Radiology, Zhujiang Hospital of Southern Medical University
city: Harbin
country: China
facility: Department of Radiology, Harbin University The Fourth Affiliated Hospital
city: Jinan
country: China
facility: Shandong Medical Imaging Research Institute
city: Nanjing
country: China
facility: Department of Radiology, Nanjing Drum Tower Hospital
city: Qiqihar
country: China
facility: Department of Radiology, The First Hospital of Qiqihaer City
city: Shanghai
country: China
facility: Department of Radiology, Shanghai Renji Hospital
city: Tianjin
country: China
facility: Department of Radiology, Tianjin Fourth Centre Hospital
city: Xining
country: China
facility: Department of Radiology, Qinghai University Affiliated Hospital
Study officials:
affiliation: Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University
name: Chun Yuan, PhD
role: PRINCIPAL_INVESTIGATOR
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