Office Practice Assessment of Carotid Atherosclerosis Using Handheld Ultrasound (OPACA) Study
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 45 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | April 2006 |
| End Date: | September 2007 |
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.
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
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
Inclusion Criteria:
- Males over 45 years and females over 55 years of age with at least one additional
risk factor for coronary artery disease.
- Females 45-54 years old may be enrolled if they have a family history of CHD
(myocardial infarction, coronary artery bypass graft surgery, angioplasty, sudden
cardiac death) in a male first degree relative <55 or a female first degree relative
<65 years old AND at least one additional risk factor for coronary artery disease.
Exclusion Criteria:
- Age >70 years
- Subjects taking cholesterol-lowering medications
- Active liver disease
- Active thyroid disease
- Uncontrolled hypertension
- Chronic kidney disease
- History of coronary artery disease
- History of cerebrovascular disease
- History of peripheral arterial disease
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