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Carotid AtherosclerosisNCT04544657

Artificial Intelligence Based Comprehensive Assessment System of Carotid Plaque Stability

An observational study of Carotid Atherosclerosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Carotid Atherosclerosis
How many people
2,000 participants
Where
1 siteChina
Study dates
1 Jan 2019to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with carotid plaque admitted to the outpatient, physical examination and inpatient department of our hospital.

Who may be able to join

  • Age < 18 years and < 80 years
  • At least one imaging examination suggested the presence of carotid plaque
  • no allergy to contrast-enhanced ultrasound and other contraindications
  • Voluntary enrollment in this study.

Who cannot join

  • Patients unable to cooperate with posture or hold their breath during ultrasound examination
  • Patients with serious lack of clinical data
  • drugs for carotid plaque treatment other than lipid-lowering drugs, antiplatelet drugs, antioxidants, calcium channel blockers were used during follow-up
  • patients with loss of Union during follow-up
  • ischemic stroke caused by non-carotid plaque shedding
  • atriumPatients with tremor and other serious heart diseases.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Second Affiliated Hospital,School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310000

    Pintong Huang, PHD, 18857168333 ext. +86, huangpintong@zju.edu.cn

    Tao Jiang, Master, 13675853475 ext. +86, jiangtao3425@qq.com

    Recruiting

Other trials in China

About this study

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.Deep learning is the hottest research method in AI at present. [Deep learning is essentially to construct machine learning models with multiple hidden layers, and use large-scale data to train to obtain a large number of more representative feature information, so as to use these features to classify and predict samples. At present, it is widely used in the field of image analysis and plays an important role in medicine.Such as pathological image detection, regulatory genomics research, diagnosis of retinopathy and quantitative analysis of liver fibrosis, etc.Computational Fluid Dynamics (CFD) is a new discipline developed by the combination of numerical calculation and classical fluid mechanics theory. It can make it convenient for researchers to build a geometric model of cardiovascular system, simulate the real structure of vascular wall and blood, and display the results of "numerical experiments" using visualization technology.More intuitive Comprehensive response to changes in hemodynamic parameters In recent years, its application in cardiovascular hemodynamic research has become increasingly widespread, with a large number of relevant literature reports However, no report has been reported on the study of carotid plaque stability and fluid dynamics using this technology Based on the above reasons,This study attempts to use AI technology to automatically identify and quantitatively evaluate the gray scale differences of plaques, elastic image characteristics of plaques, microvessel density division of plaque contrast-enhanced ultrasound, and velocity vector imaging (VVI) to determine plaque surface stress.To study the effect of hemodynamic parameters on carotid plaque using CFD technology, and to establish a systematic comprehensive evaluation system for carotid plaque stability, which integrates two-dimensional plaque information, texture information, microcirculation perfusion information, biomechanical information and blood flow field information, and combines the results of clinical follow-up and collagen fiber content of surgical specimens, MMP9/CD34 and other examinations.

Being tested
no intervention
Keywords
ultrasound;Atherosclerosis
Medical subject headings
Carotid Artery Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no interventionOther

    No intervention for enrolled patients

Study groups in NCT04544657
Study groupRoleWhat they receive
stroke groupNot described
Receives: Other: no intervention
normal groupNot described
Receives: Other: no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A carotid plaque stability assessment system

    A systematic comprehensive evaluation system for carotid plaque stability, which integrates plaque two-dimensional information, texture information, microcirculation perfusion information, biomechanical information and blood flow field information

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2020
  2. Study start1 Jan 2019
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04544657
Sponsor's protocol ID
2020001523
Status last verified
Jan 2021
First submitted
26 Jun 2020
Last updated
14 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Carotid Atherosclerosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pintong Huang, PHD (18857168333 ext. +86, huangpintong@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A carotid plaque stability assessment system (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.

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