Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417586
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2006-12-28
Brief Title:
Cost-Effectiveness of a Specialized Ultrasound Instrument to Diagnose Carotid Stenosis as a Way to Reduce the Risk of Stroke
Sponsor:
DVX LLC
Organization:
DVX LLC
Study Overview
Official Title:
New Ultrasound Instrument for Carotid Screening
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 individuals 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 physicians 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
In this study nurses in selected physicians 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44HL072534-02A1 | NIH | None | httpsreporternihgovquickSearchR44HL072534-02A1 |
| R44HL072534 | NIH | None | None |