Carotid Artery PlaqueNCT04237064
Photoacoustic Imaging of Atherosclerotic Plaques
An observational study of Carotid Artery Plaque, run by Marc van Sambeek at 1 site in Netherlands.
Trial summary
Stroke is a major cause of death and disability worldwide. Stenotic carotid arteries can lead to stroke if the cause of the stenosis is a vulnerable atherosclerotic plaque. Recent studies reveal that if a patient has a plaque in the carotid artery it is highly probable that he/she will develop plaques in other… 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?
- Photoacoustic imaging
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Feb 2019to 31 Dec 2020
- 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
- Adult, Older adult
Study population: In this study, patients in the age of > 18 year will be included that are scheduled for an endarterectomy procedure at CZE.
Who may be able to join
- In order to be eligible to participate in this study, a subject must be an adult that is fully competent to give informed consent that has been under surveillance for a plaque in one of the carotid arteries with a stenosis grade between 70 and 99% (based on prior Duplex US examination in the vascular lab) In case of study A, the subject should physically be able to be seated in a chair without moving for 10 to 20 minutes.
Who cannot join
- Minors or incapacitated adults will not be included in the study. Subjects that do not want to participate will also not be included. -
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Catharina Hospital Eindhoven
Eindhoven, North Brabant, 5623EJ
Marc RHM van Sambeek, MD PhD, +31402397155, marc.v.sambeek@catharinaziekenhuis.nl
About this study
Stroke is a major cause of death and disability worldwide. Stenotic carotid arteries can lead to stroke if the cause of the stenosis is a vulnerable atherosclerotic plaque. Recent studies reveal that if a patient has a plaque in the carotid artery it is highly probable that he/she will develop plaques in other superficial arteries like the femoral artery. Currently, duplex ultrasound is used to determine the grade of stenosis and is the main criterion for intervention (endarterectomy) planning. However, the stability, or instability of the plaque cannot be determined non-invasively. Photoacoustics is a novel, non-invasive imaging modality that uses pulsed laser light to generate laser induced ultrasound in the absorbing region of the tissue. Photoacoustic imaging provides optical contrast of biological tissue chromophores with an acoustic resolution and imaging depth, which is promising for visualization of plaque composition. The advantage of photoacoustics is the use of multiple wavelengths, since different tissues respond differently to different wavelengths. Hence, non-invasive, in vivo, morphology assessment is a future application of this new modality that would improve diagnosis and clinical decision making. The drawback is the limited penetration depth of the laser light and the signals generated by surrounding tissue.
A new, integrated photoacoustic device has been developed that meets all safety requirements and has an improved penetration depth, suitable for imaging of carotid arteries with the aim to distinguish between plaques with different morphology.
Read the detailed description
Objective: The aim of this study is to investigate the feasibility of atherosclerotic plaque imaging using multispectral photoacoustic imaging.
Study design: This is a pilot study where 60 patients with a plaque in one of the carotids, scheduled for an endarterectomy procedure, will be included. Each subject will get a multi-wavelength photoacoustic examination of the carotid plaque. In one group (N = 30), photoacoustic imaging will be performed noninvasively at the TU/e laser lab, which is compliant with laser safety standards, to verify non-invasive, multi-angle, multi-wavelength photoacoustic imaging (Study A). In the second group (N = 30), photoacoustic imaging will be performed pre- and per-operatively (Study B) prior to plaque removal. Here, to ensure a 100% (laser) safe environment, all acquisitions will be performed in the operating theatre. The latter group will be subjected to additional Magnetic Resonance Imaging for validation. After carotid endarterectomie the plaque sample of each patient (Study A and B) will be transported to TU/e for in vitro PA scanning and histology analysis.
Study population: A total of 60 patients with carotid artery disease scheduled for endarterectomy (stenosis grade of > 70% and < 99%).
Intervention (if applicable): endarterectomy (following normal procedure), with an additional photoacoustic image acquisition after incision, before removal of the plaque.
Main study parameters/endpoints: The acoustic (i.e., echographic) and photoacoustic images will be analyzed to determine the ability of distinguishing between different plaque components (intraplaque hemorrhage, lipid pool, vessel wall), examine penetration depth, resolution, and contrast.
- Conditions
- Carotid Artery Plaque
- Being tested
- Photoacoustic 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.
Photoacoustic imagingDiagnostic test
Photoacoustic imaging
| Study group | Role | What they receive |
|---|---|---|
| Patients with carotid artery stenosis | In this study, patients in the age of > 18 year will be included that are scheduled for an endarterectomy procedure at CZE. Receives: Diagnostic Test: Photoacoustic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of vulnerable plaque
Demonstration of the feasibility of in vivo photoacoustic imaging of atherosclerotic plaques using multi-angle, multi-wavelength photoacoustics.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start2 Feb 2019
- Primary completion1 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marc van Sambeek
- Sponsor type
- University, hospital or other
- Collaborators
- Eindhoven University of Technology
- Responsible party
- Sponsor-investigator, Marc van Sambeek, Catharina Ziekenhuis Eindhoven
- Investigators
- Marc RHM van Sambeek, MD PhD, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237064
- Sponsor's protocol ID
- R17.029
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2020
- Last updated
- 22 Jan 2020
- 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 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoacoustic Imaging of Atherosclerotic Plaques
- ClinicalTrials.gov ID
- NCT04237064
- Acronym / sponsor ID
- R17.029
- Conditions
- Carotid Artery Plaque
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marc van SambeekUniversity, hospital or other
- Collaborators
- Eindhoven University of Technology
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 22 Jan 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 major cause of death and disability worldwide. Stenotic carotid arteries can lead to stroke if the cause of the stenosis is a vulnerable atherosclerotic plaque. Recent studies reveal that if a patient has a plaque in the carotid artery it is highly probable that he/she will develop plaques in other superficial arteries like the femoral artery. Currently, duplex ultrasound is used to determine the grade of stenosis and is the main criterion for intervention (endarterectomy) planning. However, the stability, or instability of the plaque cannot be determined non-invasively. Photoacoustics is a novel, non-invasive imaging modality that uses pulsed laser light to generate laser induced ultrasound in the absorbing region of the tissue. Photoacoustic imaging provides optical contrast of biological tissue chromophores with an acoustic resolution and imaging depth, which is promising for visualization of plaque composition. The advantage of photoacoustics is the use of multiple wavelengths, since different tissues respond differently to different wavelengths. Hence, non-invasive, in vivo, morphology assessment is a future application of this new modality that would improve diagnosis and clinical decision making. The drawback is the limited penetration depth of the laser light and the signals generated by surrounding tissue.
A new, integrated photoacoustic device has been developed that meets all safety requirements and has an improved penetration depth, suitable for imaging of carotid arteries with the aim to distinguish between plaques with different morphology.
Detailed description
Objective: The aim of this study is to investigate the feasibility of atherosclerotic plaque imaging using multispectral photoacoustic imaging.
Study design: This is a pilot study where 60 patients with a plaque in one of the carotids, scheduled for an endarterectomy procedure, will be included. Each subject will get a multi-wavelength photoacoustic examination of the carotid plaque. In one group (N = 30), photoacoustic imaging will be performed noninvasively at the TU/e laser lab, which is compliant with laser safety standards, to verify non-invasive, multi-angle, multi-wavelength photoacoustic imaging (Study A). In the second group (N = 30), photoacoustic imaging will be performed pre- and per-operatively (Study B) prior to plaque removal. Here, to ensure a 100% (laser) safe environment, all acquisitions will be performed in the operating theatre. The latter group will be subjected to additional Magnetic Resonance Imaging for validation. After carotid endarterectomie the plaque sample of each patient (Study A and B) will be transported to TU/e for in vitro PA scanning and histology analysis.
Study population: A total of 60 patients with carotid artery disease scheduled for endarterectomy (stenosis grade of > 70% and < 99%).
Intervention (if applicable): endarterectomy (following normal procedure), with an additional photoacoustic image acquisition after incision, before removal of the plaque.
Main study parameters/endpoints: The acoustic (i.e., echographic) and photoacoustic images will be analyzed to determine the ability of distinguishing between different plaque components (intraplaque hemorrhage, lipid pool, vessel wall), examine penetration depth, resolution, and contrast.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with carotid artery stenosis | – | Diagnostic Test: Photoacoustic imagingIn this study, patients in the age of > 18 year will be included that are scheduled for an endarterectomy procedure at CZE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In this study, patients in the age of > 18 year will be included that are scheduled for an endarterectomy procedure at CZE.
Key inclusion criteria (1 listed)
- In order to be eligible to participate in this study, a subject must be an adult that is fully competent to give informed consent that has been under surveillance for a plaque in one of the carotid arteries with a stenosis grade between 70 and 99% (based on prior Duplex US examination in the vascular lab) In case of study A, the subject should physically be able to be seated in a chair without moving for 10 to 20 minutes.
Key exclusion criteria (1 listed)
- Minors or incapacitated adults will not be included in the study. Subjects that do not want to participate will also not be included. -
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 |
|---|---|---|
| Photoacoustic imagingPhotoacoustic imaging | Diagnostic test | Patients with carotid artery stenosis |
Primary outcome
Assessment of vulnerable plaque
Time frame: 2 year
Demonstration of the feasibility of in vivo photoacoustic imaging of atherosclerotic plaques using multi-angle, multi-wavelength photoacoustics.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- 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.
Marc RHM van Sambeek, MD PhD principal investigator
Catharina Ziekenhuis Eindhoven
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 Marc van Sambeek at 1 site in Netherlands.
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 1 inclusion and 1 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 22 Jan 2020. 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 Netherlands. 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 Marc RHM van Sambeek, MD PhD (+31402397155, marc.v.sambeek@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of vulnerable plaque (time frame: 2 year). 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 22 Jan 2020.