Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan

NCT04057183 | Unknown

• 1 other identifier: CVRMed
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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 duplex ultrasound study.

Conditions

Carotid Stenosis

Keywords

Carotid; Stenosis; Noninvasive

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Carotid Stenotic Scan DIAGNOSTIC_TEST

Noninvasive determination of presence or absence of carotid artery stenosis

Also known as: CSS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria identify an "at-risk" population with unknown carotid artery status. The literature indicates that patients who meet the criteria have a prevalence of significant carotid artery stenosis (\>50%) of 7-10%. Current estimates are that 3 million adults in the United States have this degree of carotid artery disease with an annual stroke risk of 5-10%. Exclusion criteria are in place to identify patients in whom the status of the carotid arteries is already likely known (prior CEA or stent), have significant heart disease which will impact flow hemodynamics and create false negative or positive studies (CHF, aortic stenosis), or have excessive subcutaneous neck tissue that will attenuate and mask the CSS signal (elevated BMI).

You may qualify if:

• 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

You may not qualify if:

• Unable / unwilling to provide Informed Consent
• Prior carotid endarterectomy or carotid artery stent
• Aortic stenosis
• Congestive heart failure
• BMI \> 35

Sponsors & Collaborators

• Phillip J Bendick: lead

Study Sites (2)

Michigan Vascular Center

Flint, Michigan, 48507, United States

NOT YET RECRUITING

Wake Forest Medical Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Phillip J Bendick, PhD

CONTACT

2483960314; pbeninnc@gmail.com

Tony Robinson

CONTACT

8105778555; tonyrobinson@cvrmed.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Coordinator

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 15, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)