AtherosclerosisUMPNCT01879397
Pilot Study of Ultrasonic Determined Carotid Plaque Composition
An observational study of Atherosclerosis, run by D. Geoffrey Vince at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Research Ultrasound Exam
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 27 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
- Age ≥40years
Who cannot join
- 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)
Show all 13Show fewer
- Unable to understand English language.
- Normal Cohort:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- Research Ultrasound Exam
- Keywords
- atherosclerosis, arteriosclerosis, carotid stenosis, carotid endarterectomy, Stroke
- Medical subject headings
- Atherosclerosis, Arteriosclerosis, Carotid Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research Ultrasound ExamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Research Ultrasound Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification Algorithm Error Rate
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startMay 2013
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- D. Geoffrey Vince
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical Solutions
- Responsible party
- Sponsor-investigator, D. Geoffrey Vince, The Cleveland Clinic
- Investigators
- D. Geoffrey Vince, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879397
- Sponsor's protocol ID
- 12-797
- Acronym
- UMP
- Status last verified
- Jul 2020
- First submitted
- 13 Jun 2013
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Mapping of Carotid Plaque Composition
- ClinicalTrials.gov ID
- NCT01879397
- Acronym / sponsor ID
- UMP / 12-797
- Conditions
- Atherosclerosis
- Keywords
- atherosclerosis, arteriosclerosis, carotid stenosis, carotid endarterectomy, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- D. Geoffrey VinceUniversity, hospital or other
- Collaborators
- Siemens Medical Solutions
- Study start
- May 2013 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEA Group | – | Device: Research Ultrasound ExamSubjects 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. |
| Normal Group | – | Device: Research Ultrasound ExamSubjects 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
- Age ≥40years
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research Ultrasound ExamCollection 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. | Device | CEA Group, Normal Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D. Geoffrey Vince, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by D. Geoffrey Vince at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification Algorithm Error Rate (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.