Chinese Atherosclerosis Risk Evaluation- Phase II

Ischemic Stroke Clinical Trial

— CARE-II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02017756
• Other study ID #: Tsinghua-985
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2013
• Last updated: December 16, 2013
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: Tsinghua University
• Contact: Xihai Zhao, MD, PhD
• Phone: 861062792662
• Email: xihaizhao[@]tsinghua.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerotic Disease
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Transient Ischemic Attack

Locations

Country	Name	City	State
China	Center for Biomedical Imaging Research, Department of Biomedical Engineering, Tsinghua University	Beijing
China	Department of Radiology, Beijing Hospital	Beijing
China	Department of Radiology, Peking University First Hospital	Beijing
China	Department of Radiology, PLA General Hospital	Beijing
China	Department of Radiology, Fujian Medical University Union Hospital	Fuzhou
China	Department of Radiology, Sun Yat-Sen Memorial Hospital	Guangzhou
China	Department of Radiology, Zhujiang Hospital of Southern Medical University	Guangzhou
China	Department of Radiology, Harbin University The Fourth Affiliated Hospital	Harbin
China	Shandong Medical Imaging Research Institute	Jinan
China	Department of Radiology, Nanjing Drum Tower Hospital	Nanjing
China	Department of Radiology, The First Hospital of Qiqihaer City	Qiqihar
China	Department of Radiology, Shanghai Renji Hospital	Shanghai
China	Department of Radiology, Tianjin Fourth Centre Hospital	Tianjin
China	Department of Radiology, Qinghai University Affiliated Hospital	Xining

Sponsors (1)

Lead Sponsor	Collaborator
Tsinghua University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011 Dec;42(12):3651-4. doi: 10.1161/STROKEAHA.111.635755. Epub 2011 Nov 3. Review. — View Citation

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. Epub 2005 Jan 13. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Carotid wall and brain infarct measurements.	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	No
Secondary	Traditional risk factors.	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	No
Secondary	Incidence and volume of carotid plaques and geographic region of subjects.	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	No