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

NCT ID: NCT00417586

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

984 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carotid Stenosis Cerebrovascular Accident

Keywords

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Specialized Doppler Ultrasound Instrument

Patients with a reading of 140 cm/sec or higher will be referred for further duplex screening

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

DVX, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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David Vilkomerson

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

Princeton Surgical Associates

Locations

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Princeton Surgical Associates

Princeton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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R44HL072534

Identifier Type: NIH

Identifier Source: secondary_id

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R44HL072534-02A1

Identifier Type: NIH

Identifier Source: secondary_id

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468

Identifier Type: -

Identifier Source: org_study_id