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

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00258973
First received: November 23, 2005
Last updated: December 11, 2007
Last verified: December 2007
History of Changes
  Purpose

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.

Condition Intervention
Atherosclerosis
 Procedure: Carotid Ultrasound performed in office practice

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Office Practice Assessment of Carotid Atherosclerosis Using Handheld Ultrasound (OPACA) Study

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Bioequivalency of carotid IMT measurements.

Secondary Outcome Measures:
  • Variability in carotid IMT measurements
  • Intention to behavior change in patients
  • Effects of carotid IMT on physician management

Enrollment: 375
Study Start Date: April 2006
Study Completion Date: September 2007
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258973

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: James Stein, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: James H Stein, MD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00258973     History of Changes
Other Study ID Numbers: M-2005-1281
Study First Received: November 23, 2005
Last Updated: December 11, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
Hand held Ultrasound
Office practice
Atherosclerosis prevention
Ultrasound training

Additional relevant MeSH terms:
Atherosclerosis
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013