Improving Cardiovascular Risk Prediction Using Hand Held Carotid Ultrasonography Study

Phase 4

Completed

• Conditions: Atherosclerosis; Stroke
• Interventions: Other: Carotid Ultrasound

• Registration Number: NCT00574457
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-17
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-29
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects that meet the inclusion criteria invited	Carotid Ultrasound	-

Primary Outcome Measures

Name	Time	Method
To determine if non-sonographer health care professionals working in a community medical office practice setting can be trained to detect and evaluate subclinical atherosclerosis.	2 years

Secondary Outcome Measures

Name	Time	Method
To determine if carotid ultrasound performed in community office practices can improve physician use of evidence-based, risk-reducing interventions and if it can improve patient motivation to adhere to therapeutic recommendations.	2 years

Trial Locations

Locations (5)

ProHealth Care Medical Centers; 🇺🇸 Oconomowoc, Wisconsin, United States

Internal Medicine and Pediatrics, S.C.; 🇺🇸 Fort Atkinson, Wisconsin, United States

Mercy Clinic East; 🇺🇸 Janesville, Wisconsin, United States

Turke Family Medicine S.C.; 🇺🇸 Watertown, Wisconsin, United States

Moreland Family Medicine Associates, S.C.; 🇺🇸 Waukesha, Wisconsin, United States