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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Vilkomerson, DVX, LLC
ClinicalTrials.gov Identifier:
NCT00417586
First received: December 28, 2006
Last updated: December 9, 2013
Last verified: December 2013

December 28, 2006
December 9, 2013
June 2007
September 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00417586 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Primary care patients who fit inclusion criteria

  • Carotid Stenosis
  • Cerebrovascular Accident
Device: Specialized Doppler Ultrasound Instrument
Patients with a reading of 140 cm/sec or higher will be referred for further duplex screening
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
984
November 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00417586
468, R44HL072534, R44 HL072534-02A1
Yes
David Vilkomerson, DVX, LLC
DVX, LLC
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Kenneth Goldman, MD Princeton Surgical Associates
DVX, LLC
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP