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.
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
- 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
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.
- Conditions
- Carotid Atherosclerosis
- 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 group | Role | What they receive |
|---|---|---|
| stroke group | Not described Receives: Other: no intervention | |
| normal group | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted10 Sep 2020
- Study start1 Jan 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Based Comprehensive Assessment System of Carotid Plaque Stability
- ClinicalTrials.gov ID
- NCT04544657
- Acronym / sponsor ID
- 2020001523
- Conditions
- Carotid Atherosclerosis
- Keywords
- ultrasound;Atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stroke group | – | Other: no intervention |
| normal group | – | Other: no intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with carotid plaque admitted to the outpatient, physical examination and inpatient department of our hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionNo intervention for enrolled patients | Other | normal group, stroke group |
Primary outcome
A carotid plaque stability assessment system
Time frame: 4 years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.