Improving Cardiovascular Risk Prediction Using Hand Held Carotid Ultrasonography Study (MERC-CIMT)

University of Wisconsin (UW)

Status and phase

Completed

Phase 4

Conditions

Stroke

Atherosclerosis

Treatments

Other: Carotid Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT00574457

133JT68

Details and patient eligibility

About

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?

Full 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.

Enrollment

355 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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)