Cost-Effectiveness of a Specialized Ultrasound Instrument to Diagnose Carotid Stenosis as a Way to Reduce the Risk of Stroke
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Estimated Enrollment: | 1100 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2009 |
-
Device: Specialized Doppler Ultrasound Instrument
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 |
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
Contacts and Locations| Contact: Kenneth Goldman, MD | 609-921-7223 ext 226 | kmgol@verizon.net |
| Contact: Richele Lieboff | 609-635-1636 | rlieboff@hotmail.com |
| United States, New Jersey | |
| Princeton Surgical Associates | Recruiting |
| Princeton, New Jersey, United States, 08540 | |
| Contact: Kenneth Goldman 609-921-7223 | |
| Principal Investigator: Kenneth Goldman, MD | |
| Principal Investigator: | Kenneth Goldman, MD | Princeton Surgical Associates |
More Information
No publications provided
| Responsible Party: | David Vilkomerson, Ph.D., President, DVX, Llc. |
| ClinicalTrials.gov Identifier: | NCT00417586 History of Changes |
| Other Study ID Numbers: | 468, R44 HL072534-02A1 |
| Study First Received: | December 28, 2006 |
| Last Updated: | August 25, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
|
Stroke |
Additional relevant MeSH terms:
|
Carotid Stenosis Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Arterial Occlusive Diseases Vascular Diseases |
Cardiovascular Diseases Pathological Conditions, Anatomical Constriction, Pathologic Cerebral Infarction Stroke Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on June 18, 2013