Ultrasound-based Intima-Media Thickness Measurements
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Develop a standard technique and demonstrate adequate precision for measurement of intima-media thickness (IMT) for routine clinical use.
Condition |
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Carotid Artery Intima Media Thickness |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | Determination of the Precision and Clinical Utility of Ultrasound-based Intima-Media Thickness Measurements |
- The primary statistical endpoint for this study is to determine the standard deviation and 95% confidence interval of IMT measurements obtained using our standard method. [ Time Frame: Four years ] [ Designated as safety issue: No ]
- Standard deviation and 95% confidence interval of our IMT measurement method considering data subsets with variable US image quality levels, and different levels of image plane correlation. [ Time Frame: Two years ] [ Designated as safety issue: No ]
Estimated Enrollment: | 150 |
Study Start Date: | December 2002 |
Estimated Study Completion Date: | August 2012 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Men, age 35 to 65, being seen at the Mayo Clinic Department of Cardiovascular Health clinic, or has an appointment for a carotid duplex ultrasound exam.
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2
Women, age 35 to 65, being seen at the Mayo Clinic Department of Cardiovascular Health clinic, or has an appointment for a carotid duplex ultrasound exam.
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Detailed Description:
IMT is measured using software to analyze ECG-gated US image sequences acquired using a standard protocol. Two sonographers acquire images and measure IMT for 100 vessels. IMT technique standard deviation (SD) is determined by assuming normally distributed measurements, and dividing the SD of the 100 (paired) IMT differences by sqrt(2). This SD will be taken as measures of precision of the IMT technique.
![](https://webarchive.library.unt.edu/web/20121019031418im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 35 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
75 Men and 75 women, ages 35-65, being seen either at the Mayo Clinic Cardiovascular Clinic, or having an appointment for a carotid duplex ultrasound.
Inclusion Criteria:
- Must have an appointment at either the Cardiovascular Health Clinic or scheduled for a carotid ultrasound.
Exclusion Criteria:
- Carotid endarterectomy,carotid stenting, carotid repair, less than 45 degree range of motion in the neck, and/or cannot lie flat on back.
- Participants Enrolled who are found after imaging not to exhibit a ~1cm long common carotid far wall region free of focal plaque in which to measure IMT will not have their data analyzed further.
![](https://webarchive.library.unt.edu/web/20121019031418im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20121019031418im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
Responsible Party: | Nicholas J. Hangiandreou, Ph.D., Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00588484 History of Changes |
Other Study ID Numbers: | 2466-02 |
Study First Received: | December 25, 2007 |
Last Updated: | July 20, 2011 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mayo Clinic:
Carotid artery Common carotid artery Measurement Ultrasound |
ClinicalTrials.gov processed this record on October 17, 2012