Investigation of Multiple Ultrasound Techniques for the Assessment of Carotid Plaque Vulnerability

Arteriosclerosis Clinical Trial

Official title:

Investigation of Multiple Ultrasound Techniques for the Assessment of Carotid Plaque Vulnerability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04530721
• Other study ID #: 2020-460
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Pintong Huang, PHD
• Phone: 18857168333
• Email: huangpintong[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Stroke is a common clinical disease with high disability and mortality, which seriously threatens human life and health.Carotid atherosclerotic plaque rupture is an important pathogenic basis of ischemic stroke, so judging the stability of plaque has important clinical significance in preventing ischemic stroke.Ultrasound, as a convenient, rapid, noninvasive, radiation-free auxiliary examination technology, is widely used in carotid plaque stability examination.At present, there are many methods to judge the stability of carotid plaque based on ultrasound, including two-dimensional ultrasound, contrast-enhanced ultrasound, ultrasound elastography and so on. However, the results of plaque stability judgment by various technologies deviate greatly, which is not conducive to the development of standardized diagnosis and treatment strategies by clinicians.Studies have shown that because the neovascular epidermal cells in atherosclerotic plaques are imperfect, they are easy to rupture after stress, and the ruptured neovasculature will lead to intraplaque hemorrhage, thus causing plaque shedding, and eventually obstructing the cerebrovascular cause stroke.Contrast-enhanced ultrasound can sensitively detect the distribution and course of blood vessels.The plaque's softness and hardness determine its stability, while the difference of lipids, fibers and calcium in the plaque determines its softness and hardness.Real-time ultrasound elastography can provide tissue mechanical parameters, express the soft and hard of tissue with strain value, and provide important reference information for judging plaque stability.At present, elastography technology is used to reflect the hardness of plaque, so as to further judge its stability.However, the elastography parameters are prone to deviations due to the influence of the selected section and the selected region of interest.It can be seen from the above that there is currently a multi-modality method to evaluate the stability of carotid plaque using ultrasound, but there is a lack of a unified and objective reference standard for plaque stability assessment.The purpose of this study is to explore the comprehensive utilization of these modalities under the premise of optimizing each ultrasound modality to provide a unified and objective criterion for judging the stability of carotid plaque.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• At least one examination suggested the presence of carotid plaque

• Suitable for CEUS examination

• Voluntary enrollment in this study and signing of informed consent

Exclusion Criteria:

• Among ischemic brain rates caused by non-carotid plaque shedding

• Follow-up Lost

• Pregnant women

Related Conditions & MeSH terms

• Arteriosclerosis

Intervention

Other:
• no intervention
we don't do any intervention

Locations

Country	Name	City	State
China	Second Affiliated Hospital,School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of carotid plaque stability assessment criteria based on ultrasound multimodality Technology	Conventional ultrasound,CEUS,	2 years