Carotid AtherosclerosisCarotid Neo3DNCT07298655
3D Contrast Enhanced Microvascular Ultrasound of Carotid Atherosclerosis for the Detection of Carotid Plaque Neo-Revascularisation.
A study testing 3D Contrast Enhanced Microvascular Carotid Ultrasound in people with Carotid Atherosclerosis and Ultrasound, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Atherosclerotic plaques, the build-up of fatty materials within our arteries, can develop over a long period of time without causing any symptoms. These plaques may continue to grow and rupture causing narrowing and blockages of the blood vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Atherosclerosis, Ultrasound, Plaque Neovascularization
- What is being tested?
- 3D Contrast Enhanced Microvascular Carotid Ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2025to 30 Sep 2026
- Phase
- Interventional
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years old.
- Previously consent for participation in the SECURE trial and have undergone carotid CEUS.
- Found to have at least one carotid plaque present on carotid CEUS.
- Able to give informed consent to participate in the study and its procedures.
Who cannot join
- Age <18 years old.
- Unable to provide informed consent to participate in the study and its procedures.
- Allergy to microbubble contrast agents.
- Known pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Northwick Park Hospital
Harrow, HA1 3UJ
Emma Howard, MSc, +44 0208 869 2548, lnwh-tr.cardiacresearch@nhs.net
Roxy Senior
About this study
Atherosclerotic plaques, the build-up of fatty materials within our arteries, can develop over a long period of time without causing any symptoms.
These plaques may continue to grow and rupture causing narrowing and blockages of the blood vessels. This can lead to serious cardiovascular disease such as a heart attack or stroke causing over 160,000 deaths each year.
Read more
Lots of research has been done on why particular groups of people may develop atherosclerosis and controlling risk factors such as diabetes and high blood pressure go a long way to reduce people's risks. However, despite the treatments we have available and controlling these risk factors, some people unfortunately still go on to develop a potentially serious disease.
Further research has shown us that certain plaques in the blood vessels may be more vulnerable to rupturing compared to others. So far we know that plaques with thin caps, soft centres or those that are able to grow their own tiny blood vessels are more likely to rupture. We have now started to develop new imaging methods to try and help us detect these vulnerabilities. The hope is by being able to detect more vulnerable plaques we may be able to treat these earlier and therefore more effectively.
There are different scans available to try and visualise the tiny vessels within these plaques in the neck arteries. These include, MRI (a Magnetic Resonance Imaging scan, taking pictures using a small tunnel), CT (Computed Tomography, uses a ring-shaped machine to take pictures), and ultrasound. Ultrasound has the benefit of being free of ionising radiation and iodinated contrast, therefore posing less risk to patients. However, current ultrasound uses 2D ultrasound. Although this has shown promising results, our blood vessels and any plaques are 3D structures so we don't get to see the whole plaque using 2D imaging and therefore may miss important information. The available 3D probes in use at the moment are not able to visualise the tiny vessels accurately enough.
This study uses a different 3D ultrasound probe and ultrasound machine that is able to produce many more images than our usual probes. By taking images with this probe and using offline computer programmes to track the contrast through structures we hope that this system will be able to give us a visualisation of the whole plaque enabling us to detect any new blood vessels more accurately.
- Being tested
- 3D Contrast Enhanced Microvascular Carotid Ultrasound
- Keywords
- Carotid atherosclerosis, Carotid Ultrasound, Plaque Neovascularisation
- 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.
3D Contrast Enhanced Microvascular Carotid UltrasoundDiagnostic test
Patients will be cannulated in order to allow infusion of SonoVue® (Bracco, Milan) microbubble contrast agent. A 5ml vial will be made up into an infusion and given at a rate to allow adequate arterial opacification according to standard clinical practices. Initial 2D B-mode ultrasound images will be taken of the carotid arteries using a standard 3- to 11- MHz linear transducer on an EPIC CVx machine (Philips Medical Systems). This will confirm the presence of plaque and allow a scouted location for the desired row-column array transducer images. CEUS images will be taken with the 2D matrix array probe to allow comparative baseline images. Once the desired area has been located and CEUS images have confirmed plaque, the row-column array probe, manipulated by a clinician, will be used to take the 3D images. Microbubble contrast infusion will be given followed by a scan with the row-column array transducer which should take 2-5 minutes, taking multiple acquisitions if required. A member
| Study group | Role | What they receive |
|---|---|---|
| 3D contrast enhanced microvascular carotid ultrasound | Experimental | Patients will be cannulated in order to allow infusion of SonoVue® (Bracco, Milan) microbubble contrast agent. A 5ml vial will be made up into an infusion and given at a rate to allow adequate arterial opacification according to standard clinical practices. Initial 2D B-mode ultrasound images will be taken of the carotid arteries using a standard 3- to 11- MHz linear transducer on an EPIC CVx machine (Philips Medical Systems). This will confirm the presence of plaque and allow a scouted location for the desired row-column array transducer images. CEUS images will be taken with the 2D matrix array probe to allow comparative baseline images. Once the desired area has been located and CEUS images have confirmed plaque, the row-column array probe, manipulated by a clinician, will be used to take the 3D images. Microbubble contrast infusion will be given followed by a scan with the row-column array transducer which should take 2-5 minutes, taking multiple acquisitions if required. A member Receives: Diagnostic Test: 3D Contrast Enhanced Microvascular Carotid Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of carotid plaque neovascularisation
Can the 3D row-column array transducer detect intra-plaque neovascularisation in carotid plaques comparable to 2D CEUS
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start16 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective proof of concept study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roxy Senior, MD, Principal investigator, LNWH Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298655
- Sponsor's protocol ID
- CRC/2024/001
- Other IDs
- 349094
- Acronym
- Carotid Neo3D
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided