Telerobotic Ultrasound for Carotid Imaging - Feasibility Study

Rush

Status: Withdrawn

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

Treatments: Radiation: Ultrasound for Carotid Arteries; Radiation: Telerobotic Ultrasound for Carotid Arteries

Study type: Observational

Funder types: Other

Identifiers

NCT05654935

13090301-IRB01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

0 participants in 2 patient groups

Cohort A

Description:

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.

Treatment:

Radiation: Telerobotic Ultrasound for Carotid Arteries

Radiation: Ultrasound for Carotid Arteries

Cohort B

Description:

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).

Treatment:

Radiation: Telerobotic Ultrasound for Carotid Arteries

Radiation: Ultrasound for Carotid Arteries