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3D/4D Ultrasound Contrast Enhanced Imaging (CEUS) for Carotid Plaque Vulnerability (CEUS carotid)

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ClinicalTrials.gov Identifier: NCT02259257
Recruitment Status : Unknown
Verified October 2014 by Diana Gaitini MD., Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : October 8, 2014
Last Update Posted : October 8, 2014
Sponsor:
Collaborators:
Technion, Israel Institute of Technology
Rush University
Information provided by (Responsible Party):
Diana Gaitini MD., Rambam Health Care Campus

Brief Summary:
Contrast enhanced 3D/4D (3 dimension/4 dimension) ultrasound (CEUS) provides visualization of the dynamic vascular features of the plaques, in a unique spatial format using three orthogonal planes and angiogram-like images. Therefore, the observer can utilize the entire vascular system in a volumetric manner (3D). The rotation of the intra-plaque neovasculature as viewed in various angles provides a realistic representation that is more easily appreciated. Inter-observer variability for individual plaques has been assessed and inter-observer variability and inter-scan variability (the analysis of multiple images from single patients in longitudinal studies) were dependent on plaque size, with larger plaques showing lower variability. Therefore, the proposed 3D/4D vs. 2D CEUS imaging of the carotid plaque will provide added value for the depiction of the and quantification of intra-plaque blood vessel density by providing a true volumetric viewing area. This data will be correlated to the subsequent surgical specimens. The goal of the protocol is to investigate the correlation of intra-plaque blood vessel density and hemorrhage to 3D/4D CEUS vasa vasorum using quantitative software analyses. The histology methods used for quantification of hemorrhage and vessel density analyses.

Condition or disease
Atherosclerosis Stroke

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 3D/4D Ultrasound Contrast Enhanced Imaging (CEUS) for Carotid Plaque Vulnerability
Study Start Date : November 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Carotid plaque vascularization as seen on CEUS and histology compared to 3 year follow up of cardiovascular events. [ Time Frame: Post processing of CEUS will be done up to 3 years post surgery ]

    Post processing of CEUS data for carotid plaque vascularization.

    In addition all carotid artery histology specimens, routinely obtained at the time of surgery at each center, will be analyzed to include the following tissue stains: CD3, CD31, CD38 and Hemosiderin.



Biospecimen Retention:   Samples With DNA
Tissue: Carotid plaque histological specimen


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for endarterectomy due to carotid stenosis demonstrated on a previous imaging examination (exhibiting >50% intra-luminal narrowing or a maximum IMT measurement of > 1.5mm) or have experienced a CVA event (TIA/CVA) .
Criteria

Inclusion Criteria:

  • Adult subjects with known carotid artery disease will be included.
  • Subject must be able and willing to comply with study procedures and provide a signed and dated informed consent including consent for 3 year annual follow up.
  • Subjects will be screened by asking each study subject if they have known or suspected hypersensitivity to any of the components of Optison, blood, blood products of albumin. In addition, each study subject will be asked if they have a right to left or bi-directional or transient right to left cardiac shunts. If any of the above questions are answered in the positive, the patient will not be eligible for inclusion in the study.

Exclusion Criteria:

  • Female subjects of child bearing potential will be excluded.
  • The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.
  • History of acute occlusion requiring medical intervention of any artery (including aorta) within 6 months of consent.
  • Has a known or suspected hypersensitivity to any of the components of Optison, blood, blood products, or albumin.
  • Has known right to left, bi-directional or transient right to left cardiac shunts.
  • Any known contra-indications as listed on the current Optison package insert.

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): NCT02259257


Contacts
Contact: Steven B Feinstein, MD 1-312-942-5000 Steven_Feinstein@rush.edu
Contact: Diana E Gaitini, MD 972-4-8542664 d_gaitini@rambam.health.gov.il

Locations
Israel
Rambam Health Care Center Not yet recruiting
Haifa, Israel, 31096
Sub-Investigator: Dan Adam, PhD         
Sub-Investigator: Eyal Bercovich, MD         
Sponsors and Collaborators
Diana Gaitini MD.
Technion, Israel Institute of Technology
Rush University

Publications:

Responsible Party: Diana Gaitini MD., Director Ultrasound Unit, Dept of Medical Imaging, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02259257     History of Changes
Other Study ID Numbers: 226-14 RMB CTIL
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: October 8, 2014
Last Verified: October 2014

Keywords provided by Diana Gaitini MD., Rambam Health Care Campus:
carotid arteriosclerosis
contrast-enhanced ultrasound
neovascularization
quantitative analysis
3D/4D imaging
CEUS
Vasa vasorum

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases