Pilot Study of Ultrasonic Determined Carotid Plaque Composition "UMP"

Enrolling by invitation

Phase N/A Results N/A

Update History

15 Apr '17
The Summary of Purpose was updated.
New
Pilot prospective two group observational study to create a model of the carotid plaque composition based on ultrasonic backscattered signals and select clinical data.
Old
Pilot prospective two cohort observational study to create a model of the carotid plaque composition based on ultrasonic backscattered signals and select clinical data.
The gender criteria for eligibility was updated to "All."
26 Feb '16
The description was updated.
New
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: quantitative ultrasound (QUS) and acoustic radiation force impulse (ARFI) imaging data. QUS analyzes 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 QUS is an approach to use the spectral information which is sensitive to the number and nature of the scatterers. In contrast ARFI techniques are provide information on the stiffness and shear modulus of the tissue. Two ARFI techniques will be used to gather information on the carotid plaque and related tissue. ARFI is based on using a ultrasonic push pulse to slightly move the tissue (displacement on the order of microns). From this initial start two types of ARFI data are collected: image of the relative displacements of the tissue (ARFI image) and the measurement of the speed of the shear wave created by the tissue displacement (shear wave speed). The ARFI derived data and the QUS derived data 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 CEA procedure will be collected and the histology slides prepared from these plaques will be analyzed for the same regions where ARFI and QUS data were collected. This histology review provides the 'gold' standard for training and testing the algorithm. The majority of these matched sets (75%) will be used for training the algorithm. While the remainder (25%) 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.
Old
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: quantitative ultrasound (QUS) and acoustic radiation force impulse (ARFI) imaging data. QUS analyzes 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 QUS is an approach to use the spectral information which is sensitive to the number and nature of the scatterers. In contrast ARFI techniques are provide information on the stiffness and shear modulus of the tissue. Two ARFI techniques will be used to gather information on the carotid plaque and related tissue. ARFI is based on using a ultrasonic push pulse to slightly move the tissue (displacement on the order of microns). From this initial start two types of ARFI data are collected: image of the relative displacements of the tissue (ARFI image) and the measurement of the speed of the shear wave created by the tissue displacement (shear wave speed). The ARFI derived data and the QUS derived data 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 CEA procedure will be collected and the histology slides prepared from these plaques will be analyzed for the same regions where ARFI and QUS data were collected. This histology review provides the 'gold' standard for training and testing the algorithm. The majority of these matched sets (75%) will be used for training the algorithm. While the remainder (25%) 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.
18 Oct '14
The eligibility criteria were updated.
New
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.
Old
CEA Cohort: Inclusion Criteria: - Age ≥40years - Scheduled to undergo CEA for clinically significant carotid stenosis - All subjects are required to have had a duplex ultrasound exam prior to CEA. - 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.
A location was updated in Cleveland.
New
The overall status was removed for Cleveland Clinic.