Atherosclerosis Clinical Trial
Official title:
Office Practice Assessment of Carotid Atherosclerosis Using Handheld Ultrasound (OPACA) Study
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.
Phase
IV
Type (observational vs. interventional)
Observational
Currently recruiting or not?
Randomized? (or not)
No Blinded? (single, double, or open)
Primary outcome(s)
Bioequivalency of carotid IMT measurements.
Secondary outcome(s)
Variability in carotid IMT measurements Intention to behavior change in patients Effects of
carotid IMT on physician management
Type of Intervention (e.g., drug; device; behavioral)
Device
Name of Intervention
Handheld ultrasound measurement of carotid IMT
;
Time Perspective: Prospective
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