Carotid Artery DiseaseNCT05654935
Telerobotic Ultrasound for Carotid Imaging - Feasibility Study
An observational study of Carotid Artery Disease and Atherosclerosis, run by Rush University Medical Center.
Trial summary
In this proposal, the investigators will demonstrate the feasibility and noninferiority of telerobotic ultrasonography as compared to traditional manual acquisition in performing a limited carotid Duplex examination and in carotid plaque detection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery Disease, Atherosclerosis, Atheromatous Plaques
- What is being tested?
- Ultrasound for Carotid Arteries and Telerobotic Ultrasound for Carotid Arteries
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Mar 2014to 25 Mar 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study aims will be realized in two separate populations: 1. Cohort A: Includes 26 healthy volunteers >18 years of age. 2. Cohort B: Includes 100 patients ≥ 60 years of age without known carotid artery disease. These patients will be recruited from patients scheduled to receive a clinically indicated cardiac stress test or echocardiogram in the noninvasive cardiac testing area at Rush University Medical Center (Chicago, IL). Patients will be approached regarding their interest in participating in the proposed investigation while waiting for their
Who may be able to join
- Healthy volunteer
- >18 years of age
- Signed informed consent
Who cannot join
- Prior stroke or transient ischemic attack
- Prior heart attack.
- Prior angioplasty/stent of the heart artries
- Prior bypass surgery of the heart
- Known history of peripheral arterial disease claudication Peripheral arterial revascularization
- known history of carotid artery stenosis
- known history of carotid artery stenosis
- known history carotid artery dissection
About this study
In this proposal, the investigators will demonstrate the feasibility and noninferiority of telerobotic ultrasonography as compared to traditional manual acquisition in performing a limited carotid Duplex examination and in carotid plaque detection.
Read the detailed description
BACKGROUND
Ultrasonography is an inexpensive, noninvasive, radiation-free diagnostic tool that is indispensable in modern medicine. Carotid intima-media thickness (IMT) and carotid atherosclerotic plaque detection have been powerful screening tools for identifying patients at risk for cardiovascular events; including myocardial infarction, cardiac death, and stroke. The need for trained sonographers by the patient side to perform quality ultrasound studies has limited the accessibility to this imaging tool, both in terms of location and time of day. Robotic arms controlled remotely over the internet, by trained sonographers, can potentially provide easier and more ubiquitous access to ultrasonography in and outside traditional medical facilities, including remote villages in underdeveloped countries, disaster areas, battle zones, etc. In this proposal, the investigators will demonstrate the feasibility and noninferiority of telerobotic ultrasonography as compared to traditional manual acquisition in performing a limited carotid Duplex examination and in carotid plaque detection.
HYPOTHESIS:
Telerobotic ultrasound performed by an experienced sonographer over the Internet produces diagnostic images with quality similar to manual conventional imaging.
AIMS:
- Telerobotic ultrasonography produces diagnostic images of the carotid arteries at a rate that is non-inferior to those obtained using standard manual acquisition.
- Telerobotic ultrasonography can detect carotid atherosclerotic plaques at a rate that is non-inferior to the gold standard of manual acquisition.
IMPLICATIONS:
Realizing our study aims could mark a new era in ultrasonography. There are wide applications for telerobotic carotid ultrasonography in atherosclerosis screening. Furthermore, establishing the noninferiority of telerobotic carotid ultrasonography acquisition will provide a rationale for further studies in telerobotic ultrasonography, including echocardiography. This in turn has even wider clinical applications such as emergency studies in hospitals during weekends and after-hours. In addition, this could pave the way for use in disaster areas and battle zones where expert sonographers may not be available on-site.
- Conditions
- Carotid Artery Disease, Atherosclerosis, Atheromatous Plaques, Arteriosclerosis, Vascular Disease, Arterial Occlusive Diseases
- Being tested
- Ultrasound for Carotid Arteries, Telerobotic Ultrasound for Carotid Arteries
- Medical subject headings
- Carotid Artery Diseases, Atherosclerosis, Plaque, Atherosclerotic, Arteriosclerosis, Vascular Diseases, Arterial Occlusive Diseases, Stroke, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound for Carotid ArteriesRadiation
Also called Carotid Ultrasound, Ultrasonography
Cohort A: each subject will undergo two manual ultrasound image acquisitions by two different registered vascular sonographers who will be blinded to one another's images and findings.
Cohort B: each subject in Cohort B will undergo one manual ultrasound acquisition conducted at Rush University Medical Center.
Telerobotic Ultrasound for Carotid ArteriesRadiation
Also called Carotid Ultrasound, Telerobotic Ultrasonography
Cohort A: each subject will undergo two separate telerobotic acquisitions, in which the robotic arm will be controlled by two separate sonographers from Mount Sinai Medical Center (New York, NY). The sonographers controlling the robotic arm will be blinded to one another's images and to the images from the manual acquisition.
Cohort B: each subject will undergo one telerobotic ultrasound (in random sequence with the manual acquisition also performed for this cohort) acquired by a separate technologist than the technologist that acquired the subject's manual ultrasound. This acquisition will be conducted at Rush University Medical Center by a technologist blinded to the images of the manual acquisition technologist. Robotic acquisition will be manipulated from a different building at Rush University Medical Center using a broadband cellular internet signal (rather than the institutional intranet).
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Includes 26 healthy volunteers >18 years of age without history of stroke or transient ischemic attack, coronary artery disease (prior myocardial infarction, typical angina, prior percutaneous coronary revascularization, and prior coronary bypass graft surgery), and peripheral arterial disease (claudication, peripheral arterial revascularization stenting of bypass surgery). Subjects will be recruited using advertisement flyers and emails. Receives: Radiation: Ultrasound for Carotid Arteries; Radiation: Telerobotic Ultrasound for Carotid Arteries | |
| Cohort B | Includes 100 subjects ≥ 60 years of age without known carotid artery disease. These subjects will be recruited from patients scheduled to receive a clinically indicated cardiac stress test or echocardiogram in the noninvasive cardiac testing area at Rush University Medical Center (Chicago, IL). Receives: Radiation: Ultrasound for Carotid Arteries; Radiation: Telerobotic Ultrasound for Carotid Arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Quality of Telerobotic Ultrasound.
Gray scale examination of the right and left carotid arteries in 3 views: short axis view of the common carotid artery, long axis view of carotid bifurcation, and short axis view post bifurcation. Images will be analyzed for:
- Diagnostic image quality (diagnostic vs. non-diagnostic quality) by 2 reviewers blinded to image acquisition modality (manual vs. telerobotic).
- Image quality graded on a scale from 1 to 4 by the same two reviewers as 1) poor/non-diagnostic; 2) fair; 3) acceptable; 4) good/excellent.
Evaluation for diagnostic quality will be performed by two independent observers who will be blinded to the modality of image acquisition. Disagreement between observers will be resolved by a third blinded observer.
Measured: 3 months
Secondary outcomes (2)
Carotid Intima-Media Thickness (CIMT) Measurement
The subjects will be evaluated for the presence or absence of carotid artery atherosclerotic plaques. Each carotid artery (left and right) will be treated as an independent subject. Agreement analysis in the diagnosis of carotid artery plaques, between manual and telerobotic acquisition, will be performed. Identification of carotid artery plaques will be performed by two independent observers. Disagreements will be resolved by a third blinded observer.
Measured: 3 months
Subject Experience with Manual vs. Telerobotic Ultrasound
Subject experience with each imaging technique (manual vs. telerobotic) will be determined by a simple questionnaire, as follows:
- How did the subject feel during the examination? Comfortable; fairly comfortable; somewhat uncomfortable; very uncomfortable.
- Would the subject have this test again in the future? Definitely, probably; probably not, definitely not.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start26 Mar 2014
- Primary completion25 Mar 2015
- Study completion25 Mar 2016
Why it stopped: Failure to procure funding and technical logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Rami Doukky, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654935
- Sponsor's protocol ID
- 13090301-IRB01
- Status last verified
- Jan 2023
- First submitted
- 8 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerobotic Ultrasound for Carotid Imaging - Feasibility Study
- ClinicalTrials.gov ID
- NCT05654935
- Acronym / sponsor ID
- 13090301-IRB01
- Conditions
- Carotid Artery Disease, Atherosclerosis, Atheromatous Plaques, Arteriosclerosis, Vascular Disease, Arterial Occlusive Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Failure to procure funding and technical logistics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 26 Mar 2014 (actual)
- Primary completion
- 25 Mar 2015 (actual)
- Study completion
- 25 Mar 2016 (actual)
- First posted
- 16 Dec 2022 (actual)
- 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.
In this proposal, the investigators will demonstrate the feasibility and noninferiority of telerobotic ultrasonography as compared to traditional manual acquisition in performing a limited carotid Duplex examination and in carotid plaque detection.
Detailed description
BACKGROUND
Ultrasonography is an inexpensive, noninvasive, radiation-free diagnostic tool that is indispensable in modern medicine. Carotid intima-media thickness (IMT) and carotid atherosclerotic plaque detection have been powerful screening tools for identifying patients at risk for cardiovascular events; including myocardial infarction, cardiac death, and stroke. The need for trained sonographers by the patient side to perform quality ultrasound studies has limited the accessibility to this imaging tool, both in terms of location and time of day. Robotic arms controlled remotely over the internet, by trained sonographers, can potentially provide easier and more ubiquitous access to ultrasonography in and outside traditional medical facilities, including remote villages in underdeveloped countries, disaster areas, battle zones, etc. In this proposal, the investigators will demonstrate the feasibility and noninferiority of telerobotic ultrasonography as compared to traditional manual acquisition in performing a limited carotid Duplex examination and in carotid plaque detection.
HYPOTHESIS:
Telerobotic ultrasound performed by an experienced sonographer over the Internet produces diagnostic images with quality similar to manual conventional imaging.
AIMS:
- Telerobotic ultrasonography produces diagnostic images of the carotid arteries at a rate that is non-inferior to those obtained using standard manual acquisition.
- Telerobotic ultrasonography can detect carotid atherosclerotic plaques at a rate that is non-inferior to the gold standard of manual acquisition.
IMPLICATIONS:
Realizing our study aims could mark a new era in ultrasonography. There are wide applications for telerobotic carotid ultrasonography in atherosclerosis screening. Furthermore, establishing the noninferiority of telerobotic carotid ultrasonography acquisition will provide a rationale for further studies in telerobotic ultrasonography, including echocardiography. This in turn has even wider clinical applications such as emergency studies in hospitals during weekends and after-hours. In addition, this could pave the way for use in disaster areas and battle zones where expert sonographers may not be available on-site.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Radiation: Ultrasound for Carotid Arteries, Radiation: Telerobotic Ultrasound for Carotid ArteriesIncludes 26 healthy volunteers >18 years of age without history of stroke or transient ischemic attack, coronary artery disease (prior myocardial infarction, typical angina, prior percutaneous coronary revascularization, and prior coronary bypass graft surgery), and peripheral arterial disease (claudication, peripheral arterial revascularization stenting of bypass surgery). Subjects will be recruited using advertisement flyers and emails. |
| Cohort B | – | Radiation: Ultrasound for Carotid Arteries, Radiation: Telerobotic Ultrasound for Carotid ArteriesIncludes 100 subjects ≥ 60 years of age without known carotid artery disease. These subjects will be recruited from patients scheduled to receive a clinically indicated cardiac stress test or echocardiogram in the noninvasive cardiac testing area at Rush University Medical Center (Chicago, IL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study aims will be realized in two separate populations: 1. Cohort A: Includes 26 healthy volunteers >18 years of age. 2. Cohort B: Includes 100 patients ≥ 60 years of age without known carotid artery disease. These patients will be recruited from patients scheduled to receive a clinically indicated cardiac stress test or echocardiogram in the noninvasive cardiac testing area at Rush University Medical Center (Chicago, IL). Patients will be approached regarding their interest in participating in the proposed investigation while waiting for their
Key inclusion criteria (3 listed)
- Healthy volunteer
- >18 years of age
- Signed informed consent
Key exclusion criteria (8 listed)
- Prior stroke or transient ischemic attack
- Prior heart attack.
- Prior angioplasty/stent of the heart artries
- Prior bypass surgery of the heart
- Known history of peripheral arterial disease claudication Peripheral arterial revascularization
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 |
|---|---|---|
| Ultrasound for Carotid ArteriesAlso: Carotid Ultrasound, UltrasonographyCohort A: each subject will undergo two manual ultrasound image acquisitions by two different registered vascular sonographers who will be blinded to one another's images and findings. Cohort B: each subject in Cohort B will undergo one manual ultrasound acquisition conducted at Rush University Medical Center. | Radiation | Cohort A, Cohort B |
| Telerobotic Ultrasound for Carotid ArteriesAlso: Carotid Ultrasound, Telerobotic UltrasonographyCohort A: each subject will undergo two separate telerobotic acquisitions, in which the robotic arm will be controlled by two separate sonographers from Mount Sinai Medical Center (New York, NY). The sonographers controlling the robotic arm will be blinded to one another's images and to the images from the manual acquisition. Cohort B: each subject will undergo one telerobotic ultrasound (in random sequence with the manual acquisition also performed for this cohort) acquired by a separate technologist than the technologist that acquired the subject's manual ultrasound. This acquisition will be conducted at Rush University Medical Center by a technologist blinded to the images of the manual acquisition technologist. Robotic acquisition will be manipulated from a different building at Rush University Medical Center using a broadband cellular internet signal (rather than the institutional intranet). | Radiation | Cohort A, Cohort B |
Primary outcome
Diagnostic Quality of Telerobotic Ultrasound.
Time frame: 3 months
Gray scale examination of the right and left carotid arteries in 3 views: short axis view of the common carotid artery, long axis view of carotid bifurcation, and short axis view post bifurcation. Images will be analyzed for: 1. Diagnostic image quality (diagnostic vs. non-diagnostic quality) by 2 reviewers blinded to image acquisition modality (manual vs. telerobotic). 2. Image quality graded on a scale from 1 to 4 by the same two reviewers as 1) poor/non-diagnostic; 2) fair; 3) acceptable; 4) good/excellent. Evaluation for diagnostic quality will be performed by two independent observers who will be blinded to the modality of image acquisition. Disagreement between observers will be resolved by a third blinded observer.
2 secondary outcomes
Carotid Intima-Media Thickness (CIMT) Measurement
Time frame: 3 months
Subject Experience with Manual vs. Telerobotic Ultrasound
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Disease and Atherosclerosis, run by Rush University Medical Center.
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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Diagnostic Quality of Telerobotic Ultrasound. (time frame: 3 months). 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 10 Jan 2023.