Improving Cardiovascular Risk Prediction Using Hand Held Carotid Ultrasonography Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Cardiovascular Risk Prediction Using Hand-Held Carotid Ultrasonography Study

Conditions
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Atherosclerosis, Stroke

Intervention / Treatment
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* Other: Carotid Ultrasound


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All subjects that meet the inclusion criteria invited<br> | Other: Carotid Ultrasound<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Cardiovascular Risk Prevention, Carotid Ultrasound, Handheld ultrasound, Office Practice, Carotid Intima Media Thickness, Carotid Plaque