Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258973
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2005-11-23
Brief Title:
Office Practice Assessment of Carotid Atherosclerosis Using Handheld Ultrasound OPACA Study
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Office Practice Assessment of Carotid Atherosclerosis Using Handheld Ultrasound OPACA Study
Status:
COMPLETED
Status Verified Date:
2015-12
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:
The purposes of this study are to determine
1 Inter-site variability in CIMT image measurement using SonoCalcTM
2 If non-sonographer health care professionals working in an office practice setting can be trained to follow a carotid scanning protocol that permits a accurate measurement of CIMT and b determination of plaque presence
3 If a CIMT measurements and b determination of plaque presence by non-sonographer health care professionals are bioequivalent to those made by a core laboratory
4 If CIMT measurements and plaque assessment performed in office practices lead to meaningful changes in patient and physician behavior related to cardiovascular disease prevention
1 Inter-site variability in CIMT image measurement using SonoCalcTM
2 If non-sonographer health care professionals working in an office practice setting can be trained to follow a carotid scanning protocol that permits a accurate measurement of CIMT and b determination of plaque presence
3 If a CIMT measurements and b determination of plaque presence by non-sonographer health care professionals are bioequivalent to those made by a core laboratory
4 If CIMT measurements and plaque assessment performed in office practices lead to meaningful changes in patient and physician behavior related to cardiovascular disease prevention
Detailed Description:
Phase
IV
Type observational vs interventional
Observational
Currently recruiting or not
NO
Randomized or not
No Blinded single double or open
Primary outcomes
Bioequivalency of carotid IMT measurements
Secondary outcomes
Variability in carotid IMT measurements Intention to behavior change in patients Effects of carotid IMT on physician management
Type of Intervention eg drug device behavioral
Device
Name of Intervention
Handheld ultrasound measurement of carotid IMT
IV
Type observational vs interventional
Observational
Currently recruiting or not
NO
Randomized or not
No Blinded single double or open
Primary outcomes
Bioequivalency of carotid IMT measurements
Secondary outcomes
Variability in carotid IMT measurements Intention to behavior change in patients Effects of carotid IMT on physician management
Type of Intervention eg drug device behavioral
Device
Name of Intervention
Handheld ultrasound measurement of carotid IMT
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