Telerobotic Ultrasound for Carotid Imaging - Feasibility Study

NCT ID: NCT05654935

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-26
• Study Completion Date: 2016-03-25

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.

Conditions

Carotid Artery Disease; Atherosclerosis; Atheromatous Plaques; Arteriosclerosis; Vascular Disease; Arterial Occlusive Diseases; Stroke; Cardiac Death; Myocardial Infarction; Coronary Artery Disease; Cardiovascular Disease; Coronary Disease; Coronary Arteriosclerosis; Carotid Arteriosclerosis; Myocardial Ischemia; Heart Diseases; Cerebrovascular Disorders; Peripheral Vascular Disease; Cerebrovascular Accident; Cerebral Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Ultrasound for Carotid Arteries

Intervention Type: RADIATION

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 Arteries

Intervention Type: RADIATION

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).

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).

Ultrasound for Carotid Arteries

Intervention Type: RADIATION

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 Arteries

Intervention Type: RADIATION

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).

Interventions

Ultrasound for Carotid Arteries

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.

Intervention Type: RADIATION

Telerobotic Ultrasound for Carotid Arteries

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).

Intervention Type: RADIATION

Other Intervention Names

Carotid Ultrasound; Ultrasonography; Carotid Ultrasound; Telerobotic Ultrasonography

Eligibility Criteria

Inclusion Criteria

• Healthy volunteer
• >18 years of age
• Signed informed consent

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Rami Doukky

Professor of Medicine, Preventive Medicine, and Radiology, Rush University Medical Center; Interim Chief Division of Cardiology, John H. Stroger, Jr. Hospital of Cook County

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

13090301-IRB01

Identifier Type: -

Identifier Source: org_study_id