Office Practice Assessment of Carotid Atherosclerosis Using Handheld Ultrasound (OPACA) Study

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?

NO

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