Pilot Study of Ultrasonic Determined Carotid Plaque Composition
Pilot Study of Ultrasonic Determined Carotid Plaque Composition
Pilot prospective two group observational study to create a model of the carotid plaque
 composition based on ultrasonic backscattered signals and select clinical data.
Stroke is a major cause of morbidity and mortality among patients with cardiovascular disease
 and the major cause of long-term disability in the United States. Current imaging modalities
 can determine the severity of luminal stenosis resulting from plaque, as in the carotid
 arteries. However, cerebrovascular accidents (CVAs) are often associated with the rupture of
 unstable plaques located in regions with a non-significant degree of luminal stenosis. Thus
 up to 50% of high-risk atherosclerotic plaques may go undetected and untreated. Plaque
 composition is an additional and perhaps, more important risk factor for CVA rather than
 stenosis severity alone. Accurate identification of these high-risk, rupture-prone plaques
 may potentially prevent CVAs in a significant number of patients.

 The data collected during this study (ultrasonic backscatter and histologically processed
 carotid plaque) will provide the basis for a novel algorithm to add plaque composition
 information to the plaque size and location information that is currently provided by
 standard ultrasound imaging. The input parameters for the algorithm are derived from two
 types of non-invasive ultrasound data: spectral parameters and acoustic radiation force
 impulse (ARFI) data. Spectral parameters are extracted from the frequency content of the
 backscattered diagnostic ultrasound signals. These are the same signals currently used for
 imaging, however, imaging relies solely on the strength of the signal to form the image and
 ignores the spectral information. Thus spectral analysis is an approach to use the
 information which is sensitive to the number and nature of the scatterers. In contrast ARFI
 techniques provide information on the stiffness of the tissue. ARFI is based on using a
 ultrasonic push pulse to slightly move the tissue (displacement on the order of microns) and
 an image of the relative displacements of the tissue (ARFI image) is created. The ARFI
 derived data and the spectral parameters will be combined with clinically available measures
 currently used for diagnosis of carotid stenosis to form the input parameters for the
 algorithm. In order to train and test the algorithm the plaque removed during surgery will be
 collected and the histology slides prepared from these plaques. This histology review
 provides the 'gold' standard for training and testing the algorithm. The majority of these
 matched sets (67%) will be used for training the algorithm. While the remainder (33%) will
 provide a test of the accuracy of the algorithm for these types of matched data. The
 sensitivity and specificity for each tissue type defined during the histology review will be
 reported.
CEA Cohort:

 Inclusion Criteria:

 -  Age ≥40years

 -  Scheduled to undergo CEA for clinically significant carotid stenosis

 -  CEA is being performed for carotid stenosis of one or more of the following vessels:
 Internal Carotid Artery (ICA), distal end of the Common Carotid Artery (CCA), and/or
 CCA bulb.

 Exclusion Criteria:

 -  Pregnancy

 -  Prior surgery or intervention involving the carotid artery

 -  Prior stent in the carotid artery

 -  Unable to provide informed consent

 -  CEA for carotid stenosis for proximal CCA only (ICA and distal CCA are not involved)

 -  CEA is scheduled for non-atherosclerotic vascular disease (e.g.,. fibromuscular
 dysplasia or systemic vasculitis)

 -  Unable to understand English language.

 Normal Cohort:

 Inclusion Criteria

 -  Age ≥40years

 Exclusion Criteria

 -  Pregnancy

 -  Prior surgery or intervention involving the carotid artery (including CEA)

 -  Prior stent in the carotid artery

 -  Unable to provide informed consent

 -  Unable to understand English language.