Photoacoustic Imaging of Atherosclerotic Plaques
1 other identifier
observational
30
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2019
CompletedFirst Submitted
Initial submission to the registry
January 17, 2020
CompletedFirst Posted
Study publicly available on registry
January 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 22, 2020
January 1, 2020
1.8 years
January 17, 2020
January 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of vulnerable plaque
Demonstration of the feasibility of in vivo photoacoustic imaging of atherosclerotic plaques using multi-angle, multi-wavelength photoacoustics.
2 year
Study Arms (1)
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.
Interventions
Eligibility Criteria
In this study, patients in the age of \> 18 year will be included that are scheduled for an endarterectomy procedure at CZE.
You may qualify if:
- 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.
You may not qualify if:
- Minors or incapacitated adults will not be included in the study. Subjects that do not want to participate will also not be included. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marc van Sambeeklead
- Eindhoven University of Technologycollaborator
Study Sites (1)
Catharina Hospital Eindhoven
Eindhoven, North Brabant, 5623EJ, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc RHM van Sambeek, MD PhD
Catharina Ziekenhuis Eindhoven
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. dr. Marc van Sambeek
Study Record Dates
First Submitted
January 17, 2020
First Posted
January 22, 2020
Study Start
February 2, 2019
Primary Completion
December 1, 2020
Study Completion
December 31, 2020
Last Updated
January 22, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share