Pilot Study of Ultrasonic Determined Carotid Plaque Composition (UMP)

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. Read our disclaimer for details. Identifier: NCT01879397
Recruitment Status : Enrolling by invitation
First Posted : June 17, 2013
Last Update Posted : April 14, 2017
Siemens Medical Solutions
Information provided by (Responsible Party):
D. Geoffrey Vince, The Cleveland Clinic

June 13, 2013
June 17, 2013
April 14, 2017
May 2013
December 2018   (Final data collection date for primary outcome measure)
Classification Algorithm Error Rate [ Time Frame: Baseline ]
Classification of carotid artery plaque is produced by an algorithm that uses the QUS and ARFI derived parameters corresponding to a given region in the plaque to produce a classification of the plaque region into one of the following: calcium, fibrous, necrotic, or hemorrhagic. Error rates from both the training and test data sets will be reported.
Same as current
Complete list of historical versions of study NCT01879397 on Archive Site
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Pilot Study of Ultrasonic Determined Carotid Plaque Composition
Ultrasonic Mapping of 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: 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.

Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Carotid plaque removed during Carotid Endarterectomy (CEA) for subjects in the CEA Cohort will be collected and processed for production of histology slides.
Non-Probability Sample
People 40 years old or older who are scheduled for a CEA for atherosclerotic plaque removal within the carotid artery will be considered for enrollement in the CEA Cohort (anticipated enrollment of 50). A small number of people 40 years old or older with no CEA scheduled and no prior carotid intervention will be enrolled into the Normal Cohort (anticipated enrollment of 5).
Device: Research Ultrasound Exam

Collection of backscattered ultrasound data during non-invasive ultrasound exam

  • ARFI based images of the carotid artery and plaque
  • Ultrasound signals received by the ultrasound imaging system are recorded. These signals are discarded during the image formation process for a standard duplex ultrasound exam.
  • CEA Group
    Subjects with atherosclerotic stenosis of the carotid artery and are scheduled for a clinically indicated Carotid Endarterectomy (CEA) procedure to remove the atherosclerotic plaque. Prior to CEA procedure, a research ultrasound exam will be performed. The plaque tissue removed during the CEA will be collected and processed into histological slides.
    Intervention: Device: Research Ultrasound Exam
  • Normal Group
    Subjects who are not scheduled for a Carotid Endarterectomy (CEA) procedure and have had no prior carotid artery interventions. Subjects will have a Research Ultrasound Exam performed.
    Intervention: Device: Research Ultrasound Exam
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Enrolling by invitation
June 2019
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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D. Geoffrey Vince, The Cleveland Clinic
D. Geoffrey Vince
Siemens Medical Solutions
Principal Investigator: D. Geoffrey Vince, PhD The Cleveland Clinic
The Cleveland Clinic
April 2017