Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Photoacoustic Imaging of Atherosclerotic Plaques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04237064
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
Eindhoven University of Technology
Information provided by (Responsible Party):
Marc van Sambeek, Catharina Ziekenhuis Eindhoven

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.


Condition or disease Intervention/treatment
Carotid Artery Plaque Diagnostic Test: Photoacoustic imaging

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Photoacoustic Imaging of Atherosclerotic Plaques
Actual Study Start Date : February 2, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Diagnostic Test: Photoacoustic imaging
Photoacoustic imaging




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
In this study, patients in the age of > 18 year will be included that are scheduled for an endarterectomy procedure at CZE.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Minors or incapacitated adults will not be included in the study. Subjects that do not want to participate will also not be included. -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237064


Contacts
Layout table for location contacts
Contact: Marc RHM van Sambeek, MD PhD +31402397155 marc.v.sambeek@catharinaziekenhuis.nl
Contact: Jenny N Zwetsloot, Msc +31402397155 jennyzwetsloot@cze.nl

Locations
Layout table for location information
Netherlands
Catharina Hospital Eindhoven Recruiting
Eindhoven, NB, Netherlands, 5623EJ
Contact: Marc RHM van Sambeek, MD PhD    +31402397155    marc.v.sambeek@catharinaziekenhuis.nl   
Sponsors and Collaborators
Marc van Sambeek
Eindhoven University of Technology
Investigators
Layout table for investigator information
Principal Investigator: Marc RHM van Sambeek, MD PhD Catharina Ziekenhuis Eindhoven
Layout table for additonal information
Responsible Party: Marc van Sambeek, Prof. dr. Marc van Sambeek, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT04237064    
Other Study ID Numbers: R17.029
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carotid Stenosis
Plaque, Atherosclerotic
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases