Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan

Study Overview
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Brief Summary
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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 duplex ultrasound study.

Detailed Description
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Currently, carotid duplex ultrasound is the primary diagnostic tool for the evaluation 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. this test is not considered suitable for screening for disease. 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 Medical. The CSS instrument uses sensitive transducers to detect low frequency pressure fluctuations associated with flow disturbances downstream from areas of 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 either before or after the carotid duplex ultrasound.

Official Title
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Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan

Conditions
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Carotid Stenosis

Intervention / Treatment
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* Diagnostic Test: Carotid Stenotic Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age ≥ 65 years scheduled for a diagnostic carotid artery duplex ultrasound study AND with one or more of the following: Hypertension Hyperlipidemia Diabetes Tobacco usage - Current or past Known CAD/PAD Family history of early onset of atherosclerotic disease Exclusion Criteria: Unable / unwilling to provide Informed Consent Prior carotid endarterectomy or carotid artery stent Aortic stenosis Congestive heart failure BMI > 35

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Carotid Stenotic Scan|Noninvasive determination of presence or absence of carotid artery stenosis|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of CSS result to carotid artery duplex ultrasound examination | Percent agreement and negative predictive value of CSS compared to duplex ultrasound | CSS and duplex ultrasound done within one week of each other | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid, Stenosis, Noninvasive