Clinical trial NCT05654935: Telerobotic Ultrasound for Carotid Imaging - Feasibility Study
Official title: Telerobotic Ultrasound for Carotid Imaging - Feasibility Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
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
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2022-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility 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

Primary outcomes:
measure: Diagnostic Quality of Telerobotic Ultrasound.
timeFrame: 3 months
Secondary outcomes:
measure: Carotid Intima-Media Thickness (CIMT) Measurement
timeFrame: 3 months
measure: Subject Experience with Manual vs. Telerobotic Ultrasound
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: