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Status unknownNCT04530721Updated Aug 28, 2020

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

An observational study in Arteriosclerosis, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-08-28.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Arteriosclerosis

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Keywords

  • ultrasound
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In context

Arteriosclerosis

317 studies on the registry are indexed under Arteriosclerosis; 33 are open to participants now.

This study's planned enrollment of 200 is below the median of 330 across 99 observational studies indexed under Arteriosclerosis.

Browse Arteriosclerosis studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Outpatient and inpatient patients with carotid plaque in our hospital

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

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • stroke group

    Other: no intervention

  • normal group

    Other: no intervention

Interventions

  • Otherno intervention

    we don't do any intervention

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What researchers measure

Primary outcomes

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

    Conventional ultrasound,CEUS,

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • Second Affiliated Hospital,School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04530721
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Aug 28, 2020
Start date
Jan 1, 2020
Primary completion
Dec 1, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Aug 28, 2020

Study contacts

Pintong Huang, PHD
Contact
huangpintong@zju.edu.cn
18857168333 ext. +86
Tao Jiang, Master
Contact
jiangtao3425@qq.com
13675853475 ext. +86
Ying Zhang, Master
principal investigator · Ultrasound Department
Guoqiang Mo, Master
study director · Ultrasound Department

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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