Recruiting

Carotid Stenotic Scan

Sponsor:

Phillip J Bendick

Code:

NCT04057183

Conditions

Carotid Stenosis

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Carotid Stenotic Scan

Study Details

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

Study ID

NCT04057183

Start date

Jul 1, 2019

Status verified date

Aug, 2019

Completion date

Jun 30, 2020

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

Carotid Stenotic Scan

Noninvasive determination of presence or absence of carotid artery stenosis

Primary outcome measure

  • Comparison of CSS result to carotid artery duplex ultrasound examination [ Time Frame: CSS and duplex ultrasound done within one week of each other ]

Central Contacts and Locations

Central contacts

Phillip J Bendick, PhD

2483960314pbeninnc@gmail.com

Tony Robinson

8105778555tonyrobinson@cvrmed.com

Locations

Wake Forest Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Aarti Sarwal, MD

336-716-3961asarwal@wakehealth.edu

More Information

Sponsor

Phillip J Bendick

Last update posted

Aug 16, 2019

Last verified

Aug, 2019

Keywords

  • Carotid
  • Stenosis
  • Noninvasive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Phillip J Bendick on 2019-08-16.