Improving Cardiovascular Risk Prediction Using Hand Held Carotid Ultrasonography Study

Stroke Clinical Trial

— MERC-CIMT  

Official title:

Improving Cardiovascular Risk Prediction Using Hand-Held Carotid Ultrasonography Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574457
• Other study ID #: 133JT68
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2007
• Last updated: September 29, 2015
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Stroke

Intervention

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)

Locations

Country	Name	City	State
United States	Internal Medicine and Pediatrics, S.C.	Fort Atkinson	Wisconsin
United States	Mercy Clinic East	Janesville	Wisconsin
United States	ProHealth Care Medical Centers	Oconomowoc	Wisconsin
United States	Turke Family Medicine S.C.	Watertown	Wisconsin
United States	Moreland Family Medicine Associates, S.C.	Waukesha	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No