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

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?

Study Overview

• Status: Completed
• Conditions: Stroke; Atherosclerosis
• Intervention / Treatment: Other: Carotid Ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 355
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Fort Atkinson, Wisconsin, United States, 53538
      • Internal Medicine and Pediatrics, S.C.
    • Janesville, Wisconsin, United States, 53546
      • Mercy Clinic East
    • Oconomowoc, Wisconsin, United States, 53066
      • ProHealth Care Medical Centers
    • Watertown, Wisconsin, United States, 53098
      • Turke Family Medicine S.C.
    • Waukesha, Wisconsin, United States, 53188
      • Moreland Family Medicine Associates, S.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All subjects that meet the inclusion criteria invited	Other: Carotid Ultrasound; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: James H Stein, MD, University of Wisconsin Medical School and Public Heath

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: December 12, 2007
• First Submitted That Met QC Criteria: December 12, 2007
• First Posted (Estimate): December 17, 2007

Study Record Updates

• Last Update Posted (Estimate): October 1, 2015
• Last Update Submitted That Met QC Criteria: September 29, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Atherosclerosis; Carotid Ultrasound; Carotid Plaque; Carotid Intima Media Thickness; Handheld ultrasound; Cardiovascular Risk Prevention; Office Practice
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: 133JT68