Office Practice Assessment of Carotid Atherosclerosis Using Handheld Ultrasound (OPACA) Study
NCT ID: NCT00258973
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
375 participants
OBSERVATIONAL
2006-04-30
2007-09-30
Brief Summary
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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
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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
Conditions
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Study Design
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PROSPECTIVE
Interventions
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Carotid Ultrasound performed in office practice
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
70 Years
ALL
Yes
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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James Stein, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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M-2005-1281
Identifier Type: -
Identifier Source: org_study_id