Telerobotic Ultrasound for Carotid Imaging - Feasibility Study
- Conditions
- Carotid Artery DiseaseStrokeMyocardial InfarctionCerebrovascular DisordersCerebrovascular AccidentArterial Occlusive DiseasesCoronary DiseaseCarotid ArteriosclerosisHeart DiseasesCerebral Infarction
- Interventions
- Radiation: Ultrasound for Carotid ArteriesRadiation: Telerobotic Ultrasound for Carotid Arteries
- Registration Number
- NCT05654935
- Lead Sponsor
- Rush University Medical Center
- Brief 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.
- 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:
1. Telerobotic ultrasonography produces diagnostic images of the carotid arteries at a rate that is non-inferior to those obtained using standard manual acquisition.
2. 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort A Telerobotic Ultrasound for Carotid Arteries 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 Ultrasound for Carotid Arteries 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 B Ultrasound for Carotid Arteries 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 B Telerobotic Ultrasound for Carotid Arteries 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).
- Primary Outcome Measures
Name Time Method Diagnostic Quality of Telerobotic Ultrasound. 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.
- Secondary Outcome Measures
Name Time Method Subject Experience with Manual vs. Telerobotic Ultrasound 3 months Subject experience with each imaging technique (manual vs. telerobotic) will be determined by a simple questionnaire, as follows:
1. How did the subject feel during the examination? Comfortable; fairly comfortable; somewhat uncomfortable; very uncomfortable.
2. Would the subject have this test again in the future? Definitely, probably; probably not, definitely not.Carotid Intima-Media Thickness (CIMT) Measurement 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.