Improving Cardiovascular Risk Prediction Using Hand Held Carotid Ultrasonography Study

NCT00574457 | Completed Phase 4

• 1 other identifier: 133JT68
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 5

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?

Conditions

Atherosclerosis; Stroke

Keywords

Atherosclerosis; Cardiovascular Risk Prevention; Carotid Ultrasound; Handheld ultrasound; Office Practice; Carotid Intima Media Thickness; Carotid Plaque

Outcome Measures

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.

  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.

  2 years

Study Arms (1)

All subjects that meet the inclusion criteria invited

OTHER

Other: Carotid Ultrasound

Interventions

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)

All subjects that meet the inclusion criteria invited

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (5)

Internal Medicine and Pediatrics, S.C.

Fort Atkinson, Wisconsin, 53538, United States

Location

Mercy Clinic East

Janesville, Wisconsin, 53546, United States

Location

ProHealth Care Medical Centers

Oconomowoc, Wisconsin, 53066, United States

Location

Turke Family Medicine S.C.

Watertown, Wisconsin, 53098, United States

Location

Moreland Family Medicine Associates, S.C.

Waukesha, Wisconsin, 53188, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Stroke

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• James H Stein, MD

  University of Wisconsin Medical School and Public Heath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 17, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 1, 2015

Record last verified: 2015-09

Locations

US (5)