Study Stopped
Failure to procure funding and technical logistics
Telerobotic Ultrasound for Carotid Imaging - Feasibility Study
1 other identifier
observational
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2016
CompletedFirst Submitted
Initial submission to the registry
December 8, 2022
CompletedFirst Posted
Study publicly available on registry
December 16, 2022
CompletedJanuary 10, 2023
January 1, 2023
12 months
December 8, 2022
January 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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: 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.
3 months
Secondary Outcomes (2)
Carotid Intima-Media Thickness (CIMT) Measurement
3 months
Subject Experience with Manual vs. Telerobotic Ultrasound
3 months
Study Arms (2)
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 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).
Interventions
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.
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).
Eligibility Criteria
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
You may qualify if:
- Healthy volunteer
- \>18 years of age
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Preventive Medicine, and Radiology, Rush University Medical Center; Interim Chief Division of Cardiology, John H. Stroger, Jr. Hospital of Cook County
Study Record Dates
First Submitted
December 8, 2022
First Posted
December 16, 2022
Study Start
March 26, 2014
Primary Completion
March 25, 2015
Study Completion
March 25, 2016
Last Updated
January 10, 2023
Record last verified: 2023-01