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

Primary Purpose

Atherosclerosis, Stroke

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Carotid Ultrasound
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring Atherosclerosis, Cardiovascular Risk Prevention, Carotid Ultrasound, Handheld ultrasound, Office Practice, Carotid Intima Media Thickness, Carotid Plaque

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Internal Medicine and Pediatrics, S.C.
  • Mercy Clinic East
  • ProHealth Care Medical Centers
  • Turke Family Medicine S.C.
  • Moreland Family Medicine Associates, S.C.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All subjects that meet the inclusion criteria invited

Arm Description

Outcomes

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.

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.

Full Information

First Posted
December 12, 2007
Last Updated
September 29, 2015
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00574457
Brief Title
Improving Cardiovascular Risk Prediction Using Hand Held Carotid Ultrasonography Study
Acronym
MERC-CIMT
Official Title
Improving Cardiovascular Risk Prediction Using Hand-Held Carotid Ultrasonography Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Stroke
Keywords
Atherosclerosis, Cardiovascular Risk Prevention, Carotid Ultrasound, Handheld ultrasound, Office Practice, Carotid Intima Media Thickness, Carotid Plaque

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
355 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects that meet the inclusion criteria invited
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Carotid Ultrasound
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James H Stein, MD
Organizational Affiliation
University of Wisconsin Medical School and Public Heath
Official's Role
Principal Investigator
Facility Information:
Facility Name
Internal Medicine and Pediatrics, S.C.
City
Fort Atkinson
State/Province
Wisconsin
ZIP/Postal Code
53538
Country
United States
Facility Name
Mercy Clinic East
City
Janesville
State/Province
Wisconsin
ZIP/Postal Code
53546
Country
United States
Facility Name
ProHealth Care Medical Centers
City
Oconomowoc
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Facility Name
Turke Family Medicine S.C.
City
Watertown
State/Province
Wisconsin
ZIP/Postal Code
53098
Country
United States
Facility Name
Moreland Family Medicine Associates, S.C.
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States

12. IPD Sharing Statement

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Improving Cardiovascular Risk Prediction Using Hand Held Carotid Ultrasonography Study

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