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

December 1, 2015 updated by: University of Wisconsin, Madison

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

375

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalency of carotid IMT measurements.

Secondary Outcome Measures

Outcome Measure
Variability in carotid IMT measurements
Intention to behavior change in patients
Effects of carotid IMT on physician management

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

November 23, 2005

First Submitted That Met QC Criteria

November 23, 2005

First Posted (ESTIMATE)

November 28, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-2005-1281

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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