AtherosclerosisPhase 4MERC-CIMTNCT00574457
Improving Cardiovascular Risk Prediction Using Hand Held Carotid Ultrasonography Study
A Phase 4 study testing Carotid Ultrasound in people with Atherosclerosis and Stroke, run by University of Wisconsin, Madison at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Atherosclerosis, Stroke
- What is being tested?
- Carotid Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2007to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Internal Medicine and Pediatrics, S.C.
Fort Atkinson, Wisconsin, 53538
Mercy Clinic East
Janesville, Wisconsin, 53546
ProHealth Care Medical Centers
Oconomowoc, Wisconsin, 53066
Turke Family Medicine S.C.
Watertown, Wisconsin, 53098
Moreland Family Medicine Associates, S.C.
Waukesha, Wisconsin, 53188
About this study
Official title: Improving Cardiovascular Risk Prediction Using Hand-Held Carotid Ultrasonography Study
- 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?
Read the 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.
- Conditions
- Atherosclerosis, Stroke
- Being tested
- Carotid Ultrasound
- Keywords
- Atherosclerosis, Cardiovascular Risk Prevention, Carotid Ultrasound, Handheld ultrasound, Office Practice, Carotid Intima Media Thickness, Carotid Plaque
- Medical subject headings
- Atherosclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid UltrasoundOther
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)
| Study group | Role | What they receive |
|---|---|---|
| All subjects that meet the inclusion criteria invited | Other | Not described Receives: Other: Carotid Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James H Stein, MD, Principal investigator, University of Wisconsin Medical School and Public Heath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574457
- Sponsor's protocol ID
- 133JT68
- Acronym
- MERC-CIMT
- Status last verified
- Sep 2015
- First submitted
- 12 Dec 2007
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cardiovascular Risk Prediction Using Hand-Held Carotid Ultrasonography Study
- ClinicalTrials.gov ID
- NCT00574457
- Acronym / sponsor ID
- MERC-CIMT / 133JT68
- Conditions
- Atherosclerosis, Stroke
- Keywords
- Atherosclerosis, Cardiovascular Risk Prevention, Carotid Ultrasound, Handheld ultrasound, Office Practice, Carotid Intima Media Thickness, Carotid Plaque
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects that meet the inclusion criteria invited | Other | Other: Carotid Ultrasound |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid UltrasoundAll 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) | Other | All subjects that meet the inclusion criteria invited |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James H Stein, MD principal investigator
University of Wisconsin Medical School and Public Heath
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carotid Ultrasound in people with Atherosclerosis and Stroke, run by University of Wisconsin, Madison at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015; AzTrials last refreshed its copy on 2 Nov 2026.