Office Practice Assessment of Carotid Atherosclerosis Using Handheld Ultrasound (OPACA) Study - Full Text View

Purpose

The purposes of this study are to determine:

Inter-site variability in CIMT image measurement using SonoCalcTM.
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.
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.
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

MedlinePlus related topics:

Ultrasound

U.S. FDA Resources

Study Type:	Observational
Study Design:	Other, Prospective

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

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

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Keywords provided by University of Wisconsin, Madison:

Hand held Ultrasound

Office practice

Atherosclerosis prevention

Ultrasound training

Study placed in the following topic categories:

Arterial Occlusive Diseases

Atherosclerosis

Vascular Diseases

Central Nervous System Diseases

Arteriosclerosis

Brain Diseases

Carotid Artery Diseases

Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00258973