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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Four years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas J. Hangiandreou, Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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