An observational study in Carotid Artery Intima Media Thickness, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-09.
Sponsored by Mayo Clinic · Observational
Develop a standard technique and demonstrate adequate precision for measurement of intima-media thickness (IMT) for routine clinical use.
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.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
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
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
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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