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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00417586
Recruitment Status : Completed
First Posted : January 1, 2007
Last Update Posted : December 11, 2013
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David Vilkomerson, DVX, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment
Carotid Stenosis Cerebrovascular Accident 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
Actual Enrollment : 984 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: New Ultrasound Instrument for Carotid Screening
Study Start Date : June 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Intervention Details:
  • Device: Specialized Doppler Ultrasound Instrument
    Patients with a reading of 140 cm/sec or higher will be referred for further duplex screening

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care patients who fit inclusion criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00417586

United States, New Jersey
Princeton Surgical Associates
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Kenneth Goldman, MD Princeton Surgical Associates

Responsible Party: David Vilkomerson, President, DVX, LLC Identifier: NCT00417586     History of Changes
Other Study ID Numbers: 468
R44HL072534 ( U.S. NIH Grant/Contract )
R44HL072534-02A1 ( U.S. NIH Grant/Contract )
First Posted: January 1, 2007    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by David Vilkomerson, DVX, LLC:

Additional relevant MeSH terms:
Constriction, Pathologic
Carotid Stenosis
Pathological Conditions, Anatomical
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Arterial Occlusive Diseases