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Completed

NCT Number: NCT00258973

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carotid Ultrasound performed in office practice

Procedure

Primary outcomes

  1. Bioequivalency of carotid IMT measurements.

Secondary outcomes

  1. Variability in carotid IMT measurements

  2. Intention to behavior change in patients

  3. Effects of carotid IMT on physician management

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Nov 28, 2005
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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