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

NCT ID: NCT04530721

Last Updated: 2020-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Arteriosclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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stroke group

no intervention

Intervention Type OTHER

we don't do any intervention

normal group

no intervention

Intervention Type OTHER

we don't do any intervention

Interventions

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no intervention

we don't do any intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ying Zhang, Master

Role: PRINCIPAL_INVESTIGATOR

Ultrasound Department

Guoqiang Mo, Master

Role: STUDY_DIRECTOR

Ultrasound Department

Locations

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Second Affiliated Hospital,School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Pintong Huang, PHD

Role: CONTACT

18857168333 ext. +86

Tao Jiang, Master

Role: CONTACT

13675853475 ext. +86

Facility Contacts

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Pintong Huang, PHD

Role: primary

18857168333

Tao Jiang, Master

Role: backup

13675853475 ext. +86

Other Identifiers

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2020-460

Identifier Type: -

Identifier Source: org_study_id

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