Carotid Artery PlaqueNCT04318171
The Evaluation of Tomographic 3D Ultrasound for the Assessment of Vascular Pathology
An observational study of Carotid Artery Plaque, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study concentrates on providing more ultrasound image details when scanning vascular system including arterial and venous systems. A new sensor which provides 3D images is newly designed. It will be used in this study to find out whether it can change the future of vascular imaging or not. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery Plaque
- What is being tested?
- 3D Imaging.
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2021to 1 Jan 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients selected for this study must have arterial stenosis.
Who may be able to join
- ≥ 18 years age with vascular disease.
- Male / Female.
Who cannot join
- <18 years age.
- Patient with congenital vascular abnormalities/syndromes.
- Pregnant patients will not be recruited in this study. Patient's pregnancy status will be assessed on initial enrollment to exclude them from the study.
- Those unable to provide consent.
- Anyone who is taking part in any other research.
- Potential participants who might not adequately understand verbal explanations or written information given in English, or who have special communication needs.
Trial locations and contacts
1 site in 1 country.
About this study
This study concentrates on providing more ultrasound image details when scanning vascular system including arterial and venous systems.
A new sensor which provides 3D images is newly designed. It will be used in this study to find out whether it can change the future of vascular imaging or not.
Read the detailed description
Ultrasound is ideal for diagnosing vascular pathology due to its advantage of using different elements within its transducers, such as beam steering, focusing and high frame rate. It is also available and low costs when compared to other diagnostic modalities such as Computed Tomography (CT scan) and Magnetic Resonance Imaging (MRI). In addition to that, Duplex ultrasound (DUS) uses high sound waves with no ionising radiation. Therefore, it's fairly safe to the patient with long term surveillance.
DUS provides valuable information in diagnosing vascular disease due to its ability to detect flow motion within a vessel. It is, therefore, able to define whether the vessel being scanned is narrowed, diseased or blocked.
3D Ultrasound: 3D ultrasound provides images from different angles for better detection of structures being assessed. Therefore, the accuracy of the vessels and anatomical structures around is high. 3D Volume now becomes available and can be calculated and potentially benefits patients by detecting and defining those who are at risk of vascular disease.
There are three types of 3D ultrasound which are:
- Mechanical 3D
- 3D and 4D matrix scanning.
- Freehand 3D sensor. (Will be used in this project).
The targeted structures are:
Carotid arteries. Peripheral arteries including upper and lower limbs. Arteriovenous Fistula. Vein mapping pre coronary artery bypass graft (CABG).
Carotid Plaque Volume:
In 2009, a joint working coordinated efforts between the United Kingdom (UK) Vascular Societies concurred that the North American Symptomatic Carotid Endarterectomy Trial (NASCET) method for evaluating and grading carotid artery disease should be utilised in the UK.
In addition to current criteria used for grading carotid stenosis, Carotid plaque volume (CPV) is a measurement that may be a better predictive of embolic risk and stroke. CPV may be used to determine whether the patients with <70% stenosis and large plaque volume are at risk as other patients who present with >70% focal and short stenosis. A significant benefit of measuring Carotid plaque volume is observing the progression or regression of the area affected. This can be done clinically and in a quite relevant time frame.
Peripheral arterial disease (PAD):
20% of patients aged < 60 are likely to suffer from PAD including those present with intermittent claudication and also patients with critical limb ischemia (5-10%) of cases).
Uncontrolled diabetes mellitus can lead to the diabetic foot which can cause further complications such as infection, ulcer and neuropathy. DUS plays a vital role in diagnosing PAD particularly for those who are unable to be investigated by other modalities. Until now, there has been no work or research done on assessing PAD plaque volume. Investigating PAD using 3D may give an accurate diagnosis and provide more image details which can lead to a better treatment plan either by using endovascular or surgical procedures.
Arteriovenous Fistula AVF:
DUS pre and post AVF is considered the golden method of mapping and routinely assessing AVF. Renal association guidelines has stated that patients should undergo DUS for mapping in particular for those who have had previous central vein catheterisation procedures.
DUS mapping has been proven that it can positively reduce surgical complications including immediate failure. DUS also provides valuable details on AVF function and complications post creation based on current criteria including inflow and outflow volume rate. In this research, 3D US will be used to determine whether it can provide better result in compare to DUS which is currently the most widely used imaging modality.
Vein mapping:
DUS is currently used as a gold standard for vein mapping prior CABG and provides sufficient details about saphenous veins patency and suitability for using them as autogenous graft 195. 3D US may provide better image quality in demonstrating small vein branches and may improve surgical outcomes by providing more details prior to harvesting. It may also provide better details for surgeons on where to make an incision and defining the best segment of the vain is much appropriate.
- Conditions
- Carotid Artery Plaque
- Being tested
- 3D Imaging.
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Imaging.Device
When the normal Doppler assessment is done following nationally approved protocol for scanning Carotid arteries, lower and upper limb arteries, AVF and Vein mapping. PIUR tUS infinity system 3D Bluetooth motion sensor which is linked to video transmission box will be used to scan the patient's common carotid artery (CCA), internal carotid artery (ICA) and external carotid artery (ECA) in transverse view to obtain the following measurements:
- Plaque volume where detectable.
- Max area stenosis.
- Volumetric stenosis.
- Measured length.
- 3D GSM. The entire assessment should not take more than 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Carotid arteries. | No intervention is required. Routine Doppler assessment + 3D scan immediately afterwards. Receives: Device: 3D Imaging. | |
| Peripheral arteries. | No intervention is required. Routine Doppler assessment + 3D scan immediately afterwards. Receives: Device: 3D Imaging. | |
| AVF. | No intervention is required. Routine Doppler assessment + 3D scan immediately afterwards. Receives: Device: 3D Imaging. | |
| Vein mapping | No intervention is required. Routine Doppler assessment + 3D scan immediately afterwards. Receives: Device: 3D Imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peck systolic velocity
Normal peck systolic velocity (PSV) is 125cm/s. More than 250 cm/s considered 50% stenosis .
Measured: 12 weeks
Peck systolic ration
Normal peak systolic velocity rations less than 1.5 and more than 2 is considered 50% stenosis. This can be calculated by measuring the peak systolic velocity within the stenotic area divided by either pre or post stenotic area.
Measured: 12 weeks
Diameter reduction measurement
The ultrasound medicine does calculate the diameter reduction automatically when the operator places the calliper at the vessels wall.
Measured: 12 weeks
Secondary outcomes (5)
Plaque volume
3D laptop calculates the plaque volume automatically.
Measured: 12 weeks
Max area stenosis.
3D laptop calculates the plaque volume automatically.
Measured: 12 weeks
Volumetric stenosis.
3D laptop calculates the plaque volume automatically.
Measured: 12 weeks
Measured length.
3D laptop calculates the plaque volume automatically.
Measured: 12 weeks
3D GSM.
3D laptop calculates the plaque volume automatically.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 Jul 2021
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery PlaqueStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318171
- Sponsor's protocol ID
- 20HH5799
- Status last verified
- Jan 2023
- First submitted
- 16 Mar 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Tomographic 3D Ultrasound for the Assessment of Vascular Pathology
- ClinicalTrials.gov ID
- NCT04318171
- Acronym / sponsor ID
- 20HH5799
- Conditions
- Carotid Artery Plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 23 Mar 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.
This study concentrates on providing more ultrasound image details when scanning vascular system including arterial and venous systems.
A new sensor which provides 3D images is newly designed. It will be used in this study to find out whether it can change the future of vascular imaging or not.
Detailed description
Ultrasound is ideal for diagnosing vascular pathology due to its advantage of using different elements within its transducers, such as beam steering, focusing and high frame rate. It is also available and low costs when compared to other diagnostic modalities such as Computed Tomography (CT scan) and Magnetic Resonance Imaging (MRI). In addition to that, Duplex ultrasound (DUS) uses high sound waves with no ionising radiation. Therefore, it's fairly safe to the patient with long term surveillance.
DUS provides valuable information in diagnosing vascular disease due to its ability to detect flow motion within a vessel. It is, therefore, able to define whether the vessel being scanned is narrowed, diseased or blocked.
3D Ultrasound: 3D ultrasound provides images from different angles for better detection of structures being assessed. Therefore, the accuracy of the vessels and anatomical structures around is high. 3D Volume now becomes available and can be calculated and potentially benefits patients by detecting and defining those who are at risk of vascular disease.
There are three types of 3D ultrasound which are:
- Mechanical 3D
- 3D and 4D matrix scanning.
- Freehand 3D sensor. (Will be used in this project).
The targeted structures are:
Carotid arteries. Peripheral arteries including upper and lower limbs. Arteriovenous Fistula. Vein mapping pre coronary artery bypass graft (CABG).
Carotid Plaque Volume:
In 2009, a joint working coordinated efforts between the United Kingdom (UK) Vascular Societies concurred that the North American Symptomatic Carotid Endarterectomy Trial (NASCET) method for evaluating and grading carotid artery disease should be utilised in the UK.
In addition to current criteria used for grading carotid stenosis, Carotid plaque volume (CPV) is a measurement that may be a better predictive of embolic risk and stroke. CPV may be used to determine whether the patients with <70% stenosis and large plaque volume are at risk as other patients who present with >70% focal and short stenosis. A significant benefit of measuring Carotid plaque volume is observing the progression or regression of the area affected. This can be done clinically and in a quite relevant time frame.
Peripheral arterial disease (PAD):
20% of patients aged < 60 are likely to suffer from PAD including those present with intermittent claudication and also patients with critical limb ischemia (5-10%) of cases).
Uncontrolled diabetes mellitus can lead to the diabetic foot which can cause further complications such as infection, ulcer and neuropathy. DUS plays a vital role in diagnosing PAD particularly for those who are unable to be investigated by other modalities. Until now, there has been no work or research done on assessing PAD plaque volume. Investigating PAD using 3D may give an accurate diagnosis and provide more image details which can lead to a better treatment plan either by using endovascular or surgical procedures.
Arteriovenous Fistula AVF:
DUS pre and post AVF is considered the golden method of mapping and routinely assessing AVF. Renal association guidelines has stated that patients should undergo DUS for mapping in particular for those who have had previous central vein catheterisation procedures.
DUS mapping has been proven that it can positively reduce surgical complications including immediate failure. DUS also provides valuable details on AVF function and complications post creation based on current criteria including inflow and outflow volume rate. In this research, 3D US will be used to determine whether it can provide better result in compare to DUS which is currently the most widely used imaging modality.
Vein mapping:
DUS is currently used as a gold standard for vein mapping prior CABG and provides sufficient details about saphenous veins patency and suitability for using them as autogenous graft 195. 3D US may provide better image quality in demonstrating small vein branches and may improve surgical outcomes by providing more details prior to harvesting. It may also provide better details for surgeons on where to make an incision and defining the best segment of the vain is much appropriate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Carotid arteries. | – | Device: 3D Imaging.No intervention is required. Routine Doppler assessment + 3D scan immediately afterwards. |
| Peripheral arteries. | – | Device: 3D Imaging.No intervention is required. Routine Doppler assessment + 3D scan immediately afterwards. |
| AVF. | – | Device: 3D Imaging.No intervention is required. Routine Doppler assessment + 3D scan immediately afterwards. |
| Vein mapping | – | Device: 3D Imaging.No intervention is required. Routine Doppler assessment + 3D scan immediately afterwards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients selected for this study must have arterial stenosis.
Key inclusion criteria (2 listed)
- ≥ 18 years age with vascular disease.
- Male / Female.
Key exclusion criteria (6 listed)
- <18 years age.
- Patient with congenital vascular abnormalities/syndromes.
- Pregnant patients will not be recruited in this study. Patient's pregnancy status will be assessed on initial enrollment to exclude them from the study.
- Those unable to provide consent.
- Anyone who is taking part in any other research.
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 |
|---|---|---|
| 3D Imaging.When the normal Doppler assessment is done following nationally approved protocol for scanning Carotid arteries, lower and upper limb arteries, AVF and Vein mapping. PIUR tUS infinity system 3D Bluetooth motion sensor which is linked to video transmission box will be used to scan the patient's common carotid artery (CCA), internal carotid artery (ICA) and external carotid artery (ECA) in transverse view to obtain the following measurements: * Plaque volume where detectable. * Max area stenosis. * Volumetric stenosis. * Measured length. * 3D GSM. The entire assessment should not take more than 45 minutes. | Device | AVF., Carotid arteries., Peripheral arteries., Vein mapping |
Primary outcome
Peck systolic velocity
Time frame: 12 weeks
Normal peck systolic velocity (PSV) is 125cm/s. More than 250 cm/s considered 50% stenosis .
Peck systolic ration
Time frame: 12 weeks
Normal peak systolic velocity rations less than 1.5 and more than 2 is considered 50% stenosis. This can be calculated by measuring the peak systolic velocity within the stenotic area divided by either pre or post stenotic area.
Diameter reduction measurement
Time frame: 12 weeks
The ultrasound medicine does calculate the diameter reduction automatically when the operator places the calliper at the vessels wall.
5 secondary outcomes
Plaque volume
Time frame: 12 weeks
Max area stenosis.
Time frame: 12 weeks
Volumetric stenosis.
Time frame: 12 weeks
Measured length.
Time frame: 12 weeks
3D GSM.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Artery Plaque, run by Imperial College London at 1 site in United Kingdom.
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 2 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: finished, as of the sponsor's last update on 25 Jan 2023. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peck systolic velocity (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 25 Jan 2023.