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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258973
• Other study ID #: M-2005-1281
• Status: Completed
• Phase: N/A
• First received: November 23, 2005
• Last updated: December 1, 2015
• Start date: April 2006
• Est. completion date: September 2007

Study information

• Verified date: December 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Description:

Phase

IV

Type (observational vs. interventional)

Observational

Currently recruiting or not?

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases

Intervention

Procedure:
• Carotid Ultrasound performed in office practice

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalency of carotid IMT measurements.
Secondary	Variability in carotid IMT measurements
Secondary	Intention to behavior change in patients
Secondary	Effects of carotid IMT on physician management