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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia E Korcarz, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00574457
First received: December 12, 2007
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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?


Condition Intervention Phase
Atherosclerosis
Stroke
Other: Carotid Ultrasound
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Improving Cardiovascular Risk Prediction Using Hand-Held Carotid Ultrasonography Study

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 355
Study Start Date: September 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574457

Locations
United States, Wisconsin
Internal Medicine and Pediatrics, S.C.
Fort Atkinson, Wisconsin, United States, 53538
Mercy Clinic East
Janesville, Wisconsin, United States, 53546
ProHealth Care Medical Centers
Oconomowoc, Wisconsin, United States, 53066
Turke Family Medicine S.C.
Watertown, Wisconsin, United States, 53098
Moreland Family Medicine Associates, S.C.
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: James H Stein, MD University of Wisconsin Medical School and Public Heath
  More Information

No publications provided

Responsible Party: Claudia E Korcarz, Senior Scientist, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00574457     History of Changes
Other Study ID Numbers: 133JT68
Study First Received: December 12, 2007
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Atherosclerosis
Cardiovascular Risk Prevention
Carotid Ultrasound
Handheld ultrasound
Office Practice
Carotid Intima Media Thickness
Carotid Plaque

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014