Carotid Artery PlaquePhase 2NCT03335033
New Technologies to Determine Carotid Plaque Vulnerability in Patients With Significant Carotid Plaques
A Phase 2 study testing Contrast-enhanced ultrasound, Shear Wave Elastography and Ultrasound Examination in people with Carotid Artery Plaque, run by Mayo Clinic at 1 site in United States.
Trial summary
The researchers are trying to determine if the characterization of "vulnerable" carotid artery plaques can be accomplished with ultrasound-based methods that look for vessels in the plaque and measure the plaque stiffness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Plaque
- What is being tested?
- Contrast-enhanced ultrasound, Shear Wave Elastography and Ultrasound Examination
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2017to 30 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject has carotid plaque with > 50% stenosis
- Subject is able to understand the study procedure and provide informed consent
Who cannot join
- Subject is pregnant or breast feeding
- Subject is unable to provide informed consent
- Subject has contraindication to the use of the Lumason contrast agent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: New Technologies to Determine Carotid Plaque Vulnerability: A Pilot Study to Assess Contrast-Enhanced Ultrasound (CEUS) and Shear Wave Elastography (SWE) in Patients With Significant Carotid Plaques
The researchers are trying to determine if the characterization of "vulnerable" carotid artery plaques can be accomplished with ultrasound-based methods that look for vessels in the plaque and measure the plaque stiffness.
Read the detailed description
All participants will receive a one time Carotid contrast-enhanced Ultrasound (CEUS) examination that may take 30-60 minutes. Follow up calls will be made to the Participants at 6, 12 ,24 and 36 months to ask about occurrence of major adverse cardiovascular events.
- Conditions
- Carotid Artery Plaque
- Being tested
- Contrast-enhanced ultrasound, Shear Wave Elastography, Ultrasound Examination
- Keywords
- Carotid Plaque, Contrast Enhanced Ultrasound, Shear Wave Elastography, Endarterectomy, Stenosis
- Medical subject headings
- Carotid Stenosis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced ultrasoundCombination product
Also called Lumason
Subjects will receive a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.
Shear Wave ElastographyDevice
Shear wave elastography will be performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. In each plane 10 measurements will be made and the in-phase/quadrature (IQ) data will be saved for further analysis. The plaque area in the imaging plane will be user-defined to extract the wave velocity values for a ROI analysis.
Ultrasound ExaminationDevice
A standard carotid US examination using Duplex imaging will performed using a linear array transducer to obtain longitudinal and transverse images. All ultrasound measurements will be made by a trained registered vascular technologist. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Carotid Plaques with >70% Stenosis | Active comparator | Subjects being seen in the Mayo Clinic Gonda Vascular Center who have a plaque causing a > 70% stenosis will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound. Receives: Combination Product: Contrast-enhanced ultrasound; Device: Shear Wave Elastography; Device: Ultrasound Examination |
| Carotid Plaques with 50-69% Stenosis | Active comparator | Cardiovascular high-risk patients with moderate (50-69% diameter) stenosis carotid plaques from the Mayo Clinic Gonda Vascular Center will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound. Receives: Combination Product: Contrast-enhanced ultrasound; Device: Shear Wave Elastography; Device: Ultrasound Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Completed All of the Ultrasound Examinations
Total number of subjects who completed all of the ultrasound examinations to determine visualization of arterial wall (contrast-enhanced ultrasound, 3-D volume ultrasound) and its mechanical properties (shear wave elastography).
Measured: 1 year after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start15 Nov 2017
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carotid Artery PlaqueStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew W. Urban, Mayo Clinic
- Investigators
- Matthew W Urban, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335033
- Sponsor's protocol ID
- 17-001863
- Status last verified
- Nov 2022
- First submitted
- 4 Oct 2017
- Last updated
- 25 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Technologies to Determine Carotid Plaque Vulnerability: A Pilot Study to Assess Contrast-Enhanced Ultrasound (CEUS) and Shear Wave Elastography (SWE) in Patients With Significant Carotid Plaques
- ClinicalTrials.gov ID
- NCT03335033
- Acronym / sponsor ID
- 17-001863
- Conditions
- Carotid Artery Plaque
- Keywords
- Carotid Plaque, Contrast Enhanced Ultrasound, Shear Wave Elastography, Endarterectomy, Stenosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Posted 25 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are trying to determine if the characterization of "vulnerable" carotid artery plaques can be accomplished with ultrasound-based methods that look for vessels in the plaque and measure the plaque stiffness.
Detailed description
All participants will receive a one time Carotid contrast-enhanced Ultrasound (CEUS) examination that may take 30-60 minutes. Follow up calls will be made to the Participants at 6, 12 ,24 and 36 months to ask about occurrence of major adverse cardiovascular events.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotid Plaques with >70% Stenosis | Active comparator | Combination Product: Contrast-enhanced ultrasound, Device: Shear Wave Elastography, Device: Ultrasound ExaminationSubjects being seen in the Mayo Clinic Gonda Vascular Center who have a plaque causing a > 70% stenosis will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound. |
| Carotid Plaques with 50-69% Stenosis | Active comparator | Combination Product: Contrast-enhanced ultrasound, Device: Shear Wave Elastography, Device: Ultrasound ExaminationCardiovascular high-risk patients with moderate (50-69% diameter) stenosis carotid plaques from the Mayo Clinic Gonda Vascular Center will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has carotid plaque with > 50% stenosis
- Subject is able to understand the study procedure and provide informed consent
Key exclusion criteria (3 listed)
- Subject is pregnant or breast feeding
- Subject is unable to provide informed consent
- Subject has contraindication to the use of the Lumason contrast agent.
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 |
|---|---|---|
| Contrast-enhanced ultrasoundAlso: LumasonSubjects will receive a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected. | Combination product | Carotid Plaques with 50-69% Stenosis, Carotid Plaques with >70% Stenosis |
| Shear Wave ElastographyShear wave elastography will be performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. In each plane 10 measurements will be made and the in-phase/quadrature (IQ) data will be saved for further analysis. The plaque area in the imaging plane will be user-defined to extract the wave velocity values for a ROI analysis. | Device | Carotid Plaques with 50-69% Stenosis, Carotid Plaques with >70% Stenosis |
| Ultrasound ExaminationA standard carotid US examination using Duplex imaging will performed using a linear array transducer to obtain longitudinal and transverse images. All ultrasound measurements will be made by a trained registered vascular technologist. Severity of stenosis of the plaque will be measured based on established protocol and guidelines. | Device | Carotid Plaques with 50-69% Stenosis, Carotid Plaques with >70% Stenosis |
Primary outcome
Number of Subjects Who Completed All of the Ultrasound Examinations
Time frame: 1 year after recruitment
Total number of subjects who completed all of the ultrasound examinations to determine visualization of arterial wall (contrast-enhanced ultrasound, 3-D volume ultrasound) and its mechanical properties (shear wave elastography).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Matthew W Urban principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Contrast-enhanced ultrasound, Shear Wave Elastography and Ultrasound Examination in people with Carotid Artery Plaque, run by Mayo Clinic at 1 site in United States.
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 3 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 Nov 2022. 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 States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Who Completed All of the Ultrasound Examinations (time frame: 1 year after recruitment). 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 Nov 2022.