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Completed

NCT Number: NCT00574457

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?

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Carotid Ultrasound

Other

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)

Primary outcomes

  1. 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.

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Improving Cardiovascular Risk Prediction Using Hand-Held Carotid Ultrasonography Study

Acronym: MERC-CIMT

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 17, 2007
Registry last updated
Oct 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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