Cost-Effectiveness of a Specialized Ultrasound Instrument to Diagnose Carotid Stenosis as a Way to Reduce the Risk of Stroke

New Ultrasound Instrument for Carotid Screening

Carotid stenosis, a condition in which plaque builds up inside the arteries of the neck and blocks blood flow to the brain, is one common cause of stroke. This study will evaluate the cost-effectiveness of using a new, specialized ultrasound device to screen individuals who are at risk for carotid stenosis.

Study Overview

• Status: Completed
• Conditions: Carotid Stenosis; Cerebrovascular Accident
• Intervention / Treatment: Device: Specialized Doppler Ultrasound Instrument

Detailed Description

Stroke is the third leading cause of death, and the leading cause of long-term disability in the United States. At least half of all strokes are caused by carotid stenosis, a condition in which the arteries in the neck become blocked with plaque and harden. Plaque that breaks off the carotid artery wall and travels to the brain can block critical blood vessels, possibly resulting in a stroke. Carotid endarterectomy, a procedure that removes plaque buildup, can greatly reduce an individual's risk for stroke. Currently, the conventional duplex Doppler ultrasound examination that is used to screen for carotid stenosis requires a skilled sonographer or physician, and is therefore expensive. Study researchers have developed a more cost-effective option: a specialized ultrasound instrument specifically designed to perform carotid stenosis screenings and meant to be used by non-specialist nurses. Previous research has shown that this instrument is inexpensive, easy to use, and effective at diagnosing carotid stenosis. The purpose of this study is to evaluate the cost-effectiveness of the alternative ultrasound instrument at screening older adults who are at risk for carotid stenosis. If the instrument is shown to be cost-effective, it may eventually lead to widespread screening and a reduced incidence of stroke.

In this study, nurses in selected physician's offices will be trained to use the carotid ultrasound screening instrument. Patients over 65 years of age with at least one risk factor for carotid stenosis but with no symptoms will be screened with the device. Screening will take place in the doctors' offices or, when more convenient, at a central screening location; however, in all cases the nurses will use the instrument rather than specialized ultrasound technologists. Individuals found to have carotid stenosis will be referred to undergo a conventional duplex Doppler ultrasound examination for a definitive diagnosis.

• Study Type: Observational
• Enrollment (Actual): 984

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Princeton Surgical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care patients who fit inclusion criteria

Description

Inclusion Criteria:

• At least one risk factor for carotid stenosis (e.g., cardiac disease, elevated cholesterol, smoking, hypertension)

Exclusion Criteria:

• Any symptoms or indications of carotid stenosis or stroke

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: DVX, LLC
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Kenneth Goldman, MD, Princeton Surgical Associates

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: December 28, 2006
• First Submitted That Met QC Criteria: December 28, 2006
• First Posted (Estimate): January 1, 2007

Study Record Updates

• Last Update Posted (Estimate): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 9, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Stroke; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 468; R44HL072534 (U.S. NIH Grant/Contract); R44HL072534-02A1 (U.S. NIH Grant/Contract)