Carotid Artery Stenosis
Conditions
Keywords
carotid artery stenosis, plaque, carotid duplex, ultrasound, fibromsucular dysplasia, carotid atherosclerosis
Brief summary
The purpose of this study is to determine the accuracy of a new non-invasive device, the Carotid Stenotic Scan (CSS), to check for stenosis of the internal carotid artery (ICA) as compared to a carotid ultrasound study.
Detailed description
Currently, carotid duplex ultrasound is used for screening for ICA stenosis and must be performed by a trained and certified vascular technologist using advanced duplex imaging equipment and with subsequent interpretation by a trained physician. It would be of value to develop an accurate, reliable, low-cost, and easily accessible tool to screen for extra-cranial ICA disease in an office based setting. However, such a tool would require novel technology that allows for quick, accurate, reproducible, and safe evaluation. This study will evaluate a new technology called the Carotid Stenotic Scan (CSS) developed by CVR Global. The CSS instrument uses principles of cardiovascular resonance to detect low frequency pressure fluctuations associated with flow disturbances in areas of significant arterial narrowing. Subjects will undergo a clinically ordered clinical carotid duplex ultrasound as part of standard of care. Subjects will have a noninvasive CSS assessment before or after the carotid duplex ultrasound. Within 3 months following the date of the initial study visit, the electronic medical record will be queried for any interval correlative imaging studies (CTA, MRA, or angiography) and reports performed up to 1 month prior and 3 months after the duplex examination date. Report of findings will be documented (i.e., % ICA stenosis by CTA/MRA).
Interventions
DIAGNOSTIC_TESTCarotid Stenotic Scan (CSS)
Placement of the CSS instrument on the carotid arteries to measure degree of stenosis of the carotid artery. The CSS scan takes about 1-2 minutes to gather data for real-time analysis by the processor on the device cart.
Sponsors
CVR Global, Inc.
The Cleveland Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatients age \> 18 years sent to the vascular laboratory for carotid duplex examination for initial carotid ultrasound study or for follow-up of known carotid disease. * Enrolled patients will include at least 100 subjects with at least moderate known stenosis (50-69% or greater, PSV \> 125 cm/sec) or occlusion of one or both ICAs * Up to 25 patients with known fibromuscular dysplasia (FMD) of the internal carotid arteries.
Exclusion criteria
* Age \< 18 years. * Hospitalized inpatients. * Inability to provide informed consent. * Prior history of carotid endarterectomy or carotid artery stent. * Prior neck surgery * Known prosthetic heart valve, known critical aortic stenosis, or study indication preop open heart or aortic surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of CSS readings to conventional carotid artery duplex ultrasound | Baseline | Primary analysis % agreement CSS and carotid duplex ultrasound (SRUCC interpretation) for ICA stenosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility of the CSS measurement | Baseline | Each CSS measurement will be repeated and the Intraclass Correlation Coefficient (ICC) will be calculated. The ICC in an index of the reliability of measurements from the same operator |
Countries
United States
Outcome results
None listed