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

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Trial Design

  • Observation: Case-Only
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial 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) .

Outcomes

Type Measure Time Frame Safety Issue
Primary Carotid plaque vascularization as seen on CEUS and histology compared to 3 year follow up of cardiovascular events. Post processing of CEUS will be done up to 3 years post surgery No

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

Sponsors