AtherosclerosisNCT00258973
Office Practice Assessment of Carotid Atherosclerosis Using Handheld Ultrasound (OPACA) Study
An observational study of Atherosclerosis, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purposes of this study are to determine: 1. Inter-site variability in CIMT image measurement using SonoCalcTM. 2. If non-sonographer health care professionals working in an office practice setting can be trained to follow a carotid scanning protocol that permits (a) accurate measurement of CIMT and (b)… Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Carotid Ultrasound performed in office practice
- Type of treatment
- Surgery or procedure
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Sep 2007
- Phase
- Observational
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males over 45 years and females over 55 years of age with at least one additional risk factor for coronary artery disease.
- Females 45-54 years old may be enrolled if they have a family history of CHD (myocardial infarction, coronary artery bypass graft surgery, angioplasty, sudden cardiac death) in a male first degree relative <55 or a female first degree relative <65 years old AND at least one additional risk factor for coronary artery disease.
Who cannot join
- Age >70 years
- Subjects taking cholesterol-lowering medications
- Active liver disease
- Active thyroid disease
- Uncontrolled hypertension
- Chronic kidney disease
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- History of coronary artery disease
- History of cerebrovascular disease
- History of peripheral arterial disease
Trial locations and contacts
1 site in 1 country.
About this study
The purposes of this study are to determine:
- Inter-site variability in CIMT image measurement using SonoCalcTM.
- If non-sonographer health care professionals working in an office practice setting can be trained to follow a carotid scanning protocol that permits (a) accurate measurement of CIMT and (b) determination of plaque presence.
- If (a) CIMT measurements and (b) determination of plaque presence by non-sonographer health care professionals are bioequivalent to those made by a core laboratory.
- If CIMT measurements and plaque assessment performed in office practices lead to meaningful changes in patient and physician behavior related to cardiovascular disease prevention.
Read the detailed description
Phase
IV
Type (observational vs. interventional)
Observational
Currently recruiting or not?
NO
Randomized? (or not)
No Blinded? (single, double, or open)
Primary outcome(s)
Bioequivalency of carotid IMT measurements.
Secondary outcome(s)
Variability in carotid IMT measurements Intention to behavior change in patients Effects of carotid IMT on physician management
Type of Intervention (e.g., drug; device; behavioral)
Device
Name of Intervention
Handheld ultrasound measurement of carotid IMT
- Conditions
- Atherosclerosis
- Being tested
- Carotid Ultrasound performed in office practice
- Keywords
- Hand held Ultrasound, Office practice, Atherosclerosis prevention, Ultrasound training
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Ultrasound performed in office practiceProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalency of carotid IMT measurements.
Secondary outcomes (3)
Variability in carotid IMT measurements
Intention to behavior change in patients
Effects of carotid IMT on physician management
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study startApr 2006
- Study completionSep 2007
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Stein, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258973
- Sponsor's protocol ID
- M-2005-1281
- Status last verified
- Dec 2015
- First submitted
- 23 Nov 2005
- Last updated
- 3 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office Practice Assessment of Carotid Atherosclerosis Using Handheld Ultrasound (OPACA) Study
- ClinicalTrials.gov ID
- NCT00258973
- Acronym / sponsor ID
- M-2005-1281
- Conditions
- Atherosclerosis
- Keywords
- Hand held Ultrasound, Office practice, Atherosclerosis prevention, Ultrasound training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 28 Nov 2005 (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.
The purposes of this study are to determine:
- Inter-site variability in CIMT image measurement using SonoCalcTM.
- If non-sonographer health care professionals working in an office practice setting can be trained to follow a carotid scanning protocol that permits (a) accurate measurement of CIMT and (b) determination of plaque presence.
- If (a) CIMT measurements and (b) determination of plaque presence by non-sonographer health care professionals are bioequivalent to those made by a core laboratory.
- If CIMT measurements and plaque assessment performed in office practices lead to meaningful changes in patient and physician behavior related to cardiovascular disease prevention.
Detailed description
Phase
IV
Type (observational vs. interventional)
Observational
Currently recruiting or not?
NO
Randomized? (or not)
No Blinded? (single, double, or open)
Primary outcome(s)
Bioequivalency of carotid IMT measurements.
Secondary outcome(s)
Variability in carotid IMT measurements Intention to behavior change in patients Effects of carotid IMT on physician management
Type of Intervention (e.g., drug; device; behavioral)
Device
Name of Intervention
Handheld ultrasound measurement of carotid IMT
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males over 45 years and females over 55 years of age with at least one additional risk factor for coronary artery disease.
- Females 45-54 years old may be enrolled if they have a family history of CHD (myocardial infarction, coronary artery bypass graft surgery, angioplasty, sudden cardiac death) in a male first degree relative <55 or a female first degree relative <65 years old AND at least one additional risk factor for coronary artery disease.
Key exclusion criteria (9 listed)
- Age >70 years
- Subjects taking cholesterol-lowering medications
- Active liver disease
- Active thyroid disease
- Uncontrolled hypertension
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 Ultrasound performed in office practice | Procedure or surgery | – |
Primary outcome
Bioequivalency of carotid IMT measurements.
3 secondary outcomes
Variability in carotid IMT measurements
Intention to behavior change in patients
Effects of carotid IMT on physician management
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 3 Dec 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 Stein, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by University of Wisconsin, Madison at 1 site 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 2 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Bioequivalency of carotid IMT measurements.. 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 3 Dec 2015.