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

NCT04530721 | Unknown

• 1 other identifier: 2020-460
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arteriosclerosis

Keywords

ultrasound

Outcome Measures

Primary Outcomes (1)

• Accuracy of carotid plaque stability assessment criteria based on ultrasound multimodality Technology

  Conventional ultrasound，CEUS，

  2 years

Study Arms (2)

stroke group

Other: no intervention

normal group

Other: no intervention

Interventions

no intervention OTHER

we don't do any intervention

normal group; stroke group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient and inpatient patients with carotid plaque in our hospital

You may qualify if:

• At least one examination suggested the presence of carotid plaque
• Suitable for CEUS examination
• Voluntary enrollment in this study and signing of informed consent

You may not qualify if:

• Among ischemic brain rates caused by non-carotid plaque shedding
• Follow-up Lost
• Pregnant women

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital,School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Arteriosclerosis

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ying Zhang, Master

  Ultrasound Department

  PRINCIPAL INVESTIGATOR

• Guoqiang Mo, Master

  Ultrasound Department

  STUDY DIRECTOR

Central Study Contacts

Pintong Huang, PHD

CONTACT

18857168333; huangpintong@zju.edu.cn

Tao Jiang, Master

CONTACT

13675853475; jiangtao3425@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: August 28, 2020
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: August 28, 2020

Record last verified: 2020-06

Locations

CN (1)