- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05654935
Telerobotic Ultrasound for Carotid Imaging - Feasibility Study
Study Overview
Status
Conditions
- Myocardial Infarction
- Myocardial Ischemia
- Heart Diseases
- Coronary Artery Disease
- Stroke
- Cerebrovascular Disorders
- Coronary Disease
- Arteriosclerosis
- Arterial Occlusive Diseases
- Cardiovascular Disease
- Atherosclerosis
- Peripheral Vascular Disease
- Cerebral Infarction
- Coronary Arteriosclerosis
- Cerebrovascular Accident
- Cardiac Death
- Vascular Disease
- Carotid Artery Disease
- Atheromatous Plaques
- Carotid Arteriosclerosis
Intervention / Treatment
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 Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study aims will be realized in two separate populations:
- Cohort A: Includes 26 healthy volunteers >18 years of age.
- 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
Description
Inclusion Criteria for Cohort A
- Healthy volunteer
- >18 years of age
- Signed informed consent
Exclusion criteria for Cohort A include:
- 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
Exclusion criteria for Cohort B include:
- known history of carotid artery stenosis
- known history carotid artery dissection
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
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).
Other Names:
|
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).
|
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.
Other Names:
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
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. |
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Carotid Intima-Media Thickness (CIMT) Measurement
Time Frame: 3 months
|
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.
|
3 months
|
Subject Experience with Manual vs. Telerobotic Ultrasound
Time Frame: 3 months
|
Subject experience with each imaging technique (manual vs. telerobotic) will be determined by a simple questionnaire, as follows:
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pathological Conditions, Anatomical
- Brain Ischemia
- Brain Infarction
- Myocardial Infarction
- Infarction
- Heart Diseases
- Stroke
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Cardiovascular Diseases
- Vascular Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Death
- Arterial Occlusive Diseases
- Cerebral Infarction
- Arteriosclerosis
- Carotid Artery Diseases
- Atherosclerosis
- Cerebrovascular Disorders
- Plaque, Atherosclerotic
Other Study ID Numbers
- 13090301-IRB01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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