NCT00258973

Completed

Office Practice Assessment of Carotid Atherosclerosis Using ...

University of Wisconsin, Madison Source

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Other study identifiers

Sponsor study identifier

M-2005-1281

Study Type

observational

Actual enrollment (reported)

375

Locations

1 country

Sites

1

Timeline

Study Start

April 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

September 2007

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 375 participants
Study completion date: September 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 23, 2005
Actual (reported)
First Posted
November 28, 2005
Actual (reported)
Study Start
April 2006
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
September 2007
Actual (reported)

Last Updated: December 3, 2015
Status Verified: December 2015
Last Update Submitted: December 1, 2015

Conditions

Atherosclerosis

Keywords

Hand held UltrasoundOffice practiceAtherosclerosis preventionUltrasound training

Outcome Measures

Primary Outcomes (1)

Bioequivalency of carotid IMT measurements.

Secondary Outcomes (3)

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

Interventions

Carotid Ultrasound performed in office practiceProcedure

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age45 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

University of Wisconsin, Madison
Otherlead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

James Stein, MD
University of Wisconsin, Madison
PRINCIPAL INVESTIGATOR

Enrollment

375 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 23, 2005

First Posted

November 28, 2005

Study Start

April 2006

Date type not reported

This date has not been verified as actual or estimated.

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You may not qualify if:

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

Contact the study team to confirm eligibility.

Study Completion

September 2007

Actual (reported)

Last Updated

December 3, 2015

Record last verified: 2015-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00258973
Data provider: ClinicalTrials.gov
Source updated: 2015-12-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:11 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations