Clinical trial NCT00574457: Improving Cardiovascular Risk Prediction Using Hand Held Carotid Ultrasonography Study
Official title: Improving Cardiovascular Risk Prediction Using Hand-Held Carotid Ultrasonography Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atherosclerosis
Stroke
Keywords: Atherosclerosis
Cardiovascular Risk Prevention
Carotid Ultrasound
Handheld ultrasound
Office Practice
Carotid Intima Media Thickness
Carotid Plaque
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2007-12-17
Enrollment: 355
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: Fort Atkinson
country: United States
facility: Internal Medicine and Pediatrics, S.C.
state: Wisconsin
city: Janesville
country: United States
facility: Mercy Clinic East
state: Wisconsin
city: Oconomowoc
country: United States
facility: ProHealth Care Medical Centers
state: Wisconsin
city: Watertown
country: United States
facility: Turke Family Medicine S.C.
state: Wisconsin
city: Waukesha
country: United States
facility: Moreland Family Medicine Associates, S.C.
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Medical School and Public Heath
name: James H Stein, MD
role: PRINCIPAL_INVESTIGATOR
References: