Pilot Study of Ultrasonic Determined Carotid Plaque Composition (UMP)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Siemens Medical Solutions
Information provided by (Responsible Party):
D. Geoffrey Vince, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier:
NCT01879397
First received: June 13, 2013
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

Pilot prospective two cohort observational study to create a model of the carotid plaque composition based on ultrasonic backscattered signals and select clinical data.


Condition Intervention
Atherosclerosis
Device: Research Ultrasound Exam

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasonic Mapping of Carotid Plaque Composition

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Classification Algorithm Error Rate [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Biospecimen 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.


Estimated Enrollment: 55
Study Start Date: May 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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).

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879397

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
D. Geoffrey Vince
Siemens Medical Solutions
Investigators
Principal Investigator: D. Geoffrey Vince, PhD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: D. Geoffrey Vince, Department Chair, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT01879397     History of Changes
Other Study ID Numbers: 12-797
Study First Received: June 13, 2013
Last Updated: October 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
atherosclerosis
arteriosclerosis
carotid stenosis
carotid endarterectomy
Stroke

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

ClinicalTrials.gov processed this record on October 23, 2014