ClinicalTrials.gg
RecruitingNCT07298655Carotid Neo3DUpdated Apr 13, 2026

3D Contrast Enhanced Microvascular Ultrasound of Carotid Atherosclerosis for the Detection of Carotid Plaque Neo-Revascularisation.

An interventional study of 3D Contrast Enhanced Microvascular Carotid Ultrasound in Carotid Atherosclerosis, Ultrasound and Plaque Neovascularization, sponsored by London North West Healthcare NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by London North West Healthcare NHS Trust · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. This can lead to serious cardiovascular disease such as a heart attack or stroke causing over 160,000 deaths each year.

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.

02

Conditions studied

  • Carotid Atherosclerosis
  • Ultrasound
  • Plaque Neovascularization

Keywords

  • Carotid atherosclerosis
  • Carotid Ultrasound
  • Plaque Neovascularisation
03

In context

Carotid Artery Diseases

259 studies on the registry are indexed under Carotid Artery Diseases; 60 are open to participants now.

This study's planned enrollment of 10 is below the median of 144 across 120 interventional studies indexed under Carotid Artery Diseases.

Browse Carotid Artery Diseases studies →

Lead sponsor

London North West Healthcare NHS Trust is the lead sponsor of 55 studies on the registry; 11 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age>18 years old.
  2. Previously consent for participation in the SECURE trial and have undergone carotid CEUS.
  3. Found to have at least one carotid plaque present on carotid CEUS.
  4. Able to give to participate in the study and its procedures.

Exclusion criteria

Exclusion Criteria:

  1. Age \<18 years old.
  2. Unable to provide to participate in the study and its procedures.
  3. Allergy to microbubble contrast agents.
  4. Known pregnancy.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    3D contrast enhanced microvascular carotid ultrasound

    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

    Diagnostic Test: 3D Contrast Enhanced Microvascular Carotid Ultrasound

Interventions

  • Diagnostic test3D Contrast Enhanced Microvascular Carotid Ultrasound

    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

06

What researchers measure

Primary outcomes

  1. Detection of carotid plaque neovascularisation

    Can the 3D row-column array transducer detect intra-plaque neovascularisation in carotid plaques comparable to 2D CEUS

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Sep 2026, 11 months after the start.

Of 42 interventional studies with no phase under Carotid Artery Diseases, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 59. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2025
First posted
Dec 23, 2025
StartActual
Oct 16, 2025
Primary completionEst.
Sep 30, 2026
CompletionEst.
Sep 30, 2026
Last update
Apr 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07298655
Lead sponsor
London North West Healthcare NHS Trust
Responsible party
Sponsor
First posted
Dec 23, 2025
Start date
Oct 16, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Apr 13, 2026

Study contacts

Emma Howard
Contact
emma.howard16@nhs.net
0208 869 2548
Roxy Senior, MD
principal investigator · LNWH Trust

Oversight

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

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