Office Practice Assessment of Carotid Atherosclerosis Usi... | NCT00258973

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

NCT00258973

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Dec 3, 2015Estimated

Enrollment

375Actual

Phase

Not provided

Conditions

Atherosclerosis

Interventions

Carotid Ultrasound performed in office practice

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Sep 2007Actual

First Submitted Date

Nov 23, 2005

First Submission Date that Met QC Criteria

Nov 23, 2005

First Posted Date

Nov 28, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Description Module

Brief Summary

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.

Detailed Description

Phase

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

375Actual

Name	Type	Description	Arm Group Labels	Other Names
Carotid Ultrasound performed in office practice	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bioequivalency of carotid IMT measurements.

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Stein, MD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin		Madison	Wisconsin	53792	United States

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided