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
  Purpose

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 Intervention Phase
Carotid Stenosis
Cerebrovascular Accident
Device: Specialized Doppler Ultrasound Instrument
Phase 1
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: New Ultrasound Instrument for Carotid Screening

Resource links provided by NLM:


Further study details as provided by DVX, LLC:

Enrollment: 984
Study Start Date: June 2007
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Specialized Doppler Ultrasound Instrument
    Patients with a reading of 140 cm/sec or higher will be referred for further duplex screening
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care patients who fit inclusion criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417586

Locations
United States, New Jersey
Princeton Surgical Associates
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
DVX, LLC
Investigators
Principal Investigator: Kenneth Goldman, MD Princeton Surgical Associates
  More Information

No publications provided

Responsible Party: David Vilkomerson, President, DVX, LLC
ClinicalTrials.gov Identifier: NCT00417586     History of Changes
Other Study ID Numbers: 468, R44HL072534, R44 HL072534-02A1
Study First Received: December 28, 2006
Last Updated: December 9, 2013
Health Authority: United States: Federal Government

Keywords provided by DVX, LLC:
Stroke

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

ClinicalTrials.gov processed this record on August 25, 2014