Clinical trial NCT01879397: Pilot Study of Ultrasonic Determined Carotid Plaque Composition
Official title: Ultrasonic Mapping of Carotid Plaque Composition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Keywords: atherosclerosis
arteriosclerosis
carotid stenosis
carotid endarterectomy
Stroke
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
First posted: 2013-06-17
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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

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: 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.

Eligibility 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.

Primary outcomes:
measure: Classification Algorithm Error Rate
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: D. Geoffrey Vince, PhD
role: PRINCIPAL_INVESTIGATOR
References: