Cost-Effectiveness of a Specialized Ultrasound Instrument to Diagnose Carotid Stenosis as a Way to Reduce the Risk of Stroke
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|ClinicalTrials.gov Identifier: NCT00417586|
Recruitment Status : Completed
First Posted : January 1, 2007
Last Update Posted : December 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Carotid Stenosis Cerebrovascular Accident||Device: Specialized Doppler Ultrasound Instrument||Phase 1 Phase 2|
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|
|Official Title:||New Ultrasound Instrument for Carotid Screening|
|Study Start Date :||June 2007|
|Primary Completion Date :||September 2010|
|Study Completion Date :||November 2010|
Device: Specialized Doppler Ultrasound Instrument
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 ClinicalTrials.gov identifier (NCT number): NCT00417586
|United States, New Jersey|
|Princeton Surgical Associates|
|Princeton, New Jersey, United States, 08540|
|Principal Investigator:||Kenneth Goldman, MD||Princeton Surgical Associates|