Improving Cardiovascular Risk Prediction Using Hand Held Carotid Ultrasonography Study



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:40 - 70
Updated:4/21/2016
Start Date:September 2007
End Date:September 2009

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Improving Cardiovascular Risk Prediction Using Hand-Held Carotid Ultrasonography Study

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?

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.

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)
We found this trial at
5
sites
Fort Atkinson, Wisconsin 53538
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Fort Atkinson, WI
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Janesville, Wisconsin 53546
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Janesville, WI
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Oconomowoc, Wisconsin 53066
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Oconomowoc, WI
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Watertown, Wisconsin 53098
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Watertown, WI
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Waukesha, Wisconsin 53188
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Waukesha, WI
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