Improving Cardiovascular Risk Prediction Using Hand Held Carotid Ultrasonography Study

NCT ID: NCT00574457

Last Updated: 2015-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 355 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-09-30

Brief Summary

1) Research questions:

1a. Can non-sonographer health care professionals in a community medical office practice setting be trained to detect and evaluate subclinical atherosclerosis?

1b. Can carotid ultrasound performed in community office practices improve physician use of evidence-based, risk-reducing interventions and patient motivation to adhere to therapeutic recommendations?

Detailed Description

Health care providers from five medical practices will complete a 2-day training program that teaches instrumentation, scanning, measurement, quality assurance, and interpretation. They also will learn about CV risk assessment, intervention, and how to use an ultrasound-based CV risk stratification and treatment algorithm. After certification, each site will recruit 70 patients from their practice (total N=350). Subjects will complete their routine office visit and a pre-test survey designed to assess motivation and intention to change. The physician's initial plan of action based on usual care will be recorded. Next, the subject will have a standardized CV risk carotid ultrasound. The physician will revise his/her treatment plan based on the scan results and an ultrasound-based risk assessment algorithm that includes CV risk factors and ultrasound data. Evidence-based treatment recommendations for lifestyle changes and risk factor targets will be provided. The physician's scan-based plan of action will be recorded. The subject will be informed of the results and repeat the survey. All images, interpretations, and recommendations will be reviewed by the UW AIRP.

Conditions

Atherosclerosis; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

All subjects that meet the inclusion criteria invited

Group Type: OTHER

Carotid Ultrasound

Intervention Type: OTHER

All subjects that meet the inclusion criteria at each certified site will be invited to participate and go through the same intervention (questionaire-scan-post scan questionaire and 1 month follow up questionaire)

Interventions

Carotid Ultrasound

All subjects that meet the inclusion criteria at each certified site will be invited to participate and go through the same intervention (questionaire-scan-post scan questionaire and 1 month follow up questionaire)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Informed written consent from the subject prior to testing.
• Age ≥40 years old with at least 1 of the following risk factors for coronary artery disease.
• cigarette smoking
• diabetes mellitus
• hypertension (systolic blood pressure ≥140 mm Hg or taking antihypertensive medication)
• hyperlipidemia (low-density lipoprotein cholesterol ≥130 mg/dl or high-density lipoprotein cholesterol less than 40 mg/dl)
• family history of CV disease in a male first-degree relative <55 or a female first-degree relative <65 years old

Exclusion Criteria

• Age >70 years
• Use of cholesterol-lowering medications in the past year
• Known active liver disease (AST or ALT >2x upper limit of normal in home lab)
• Known active thyroid disease (TSH outside normal limits in home lab)
• Uncontrolled hypertension (blood pressure >180/100 mmHg)
• Chronic kidney disease (on dialysis or known creatinine >2.5 mg/dL)
• History of coronary artery disease (previous myocardial infarction, coronary revascularization procedure, angina pectoris with documented ischemia)
• History of cerebrovascular disease (previous stroke, transient ischemic attack, or carotid revascularization procedure)
• History of peripheral arterial disease (claudication with abnormal ankle-brachial indices or previous revascularization procedure)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James H Stein, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Medical School and Public Heath

Locations

Internal Medicine and Pediatrics, S.C.

Fort Atkinson, Wisconsin, United States

Mercy Clinic East

Janesville, Wisconsin, United States

ProHealth Care Medical Centers

Oconomowoc, Wisconsin, United States

Turke Family Medicine S.C.

Watertown, Wisconsin, United States

Moreland Family Medicine Associates, S.C.

Waukesha, Wisconsin, United States

Countries

United States

Other Identifiers

133JT68

Identifier Type: -

Identifier Source: org_study_id