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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00588484 |
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: | Cohort, Prospective |
Official Title: | Determination of the Precision and Clinical Utility of Ultrasound-Based Intima-Media Thickness Measurements |
Estimated Enrollment: | 150 |
Study Start Date: | December 2002 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (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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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.
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:
Exclusion Criteria:
Responsible Party: | Mayo Clinic ( Nicholas J. Hangiandreou, Ph.D. ) |
Study ID Numbers: | 2466-02 |
Study First Received: | December 25, 2007 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00588484 |
Health Authority: | United States: Food and Drug Administration |
Carotid artery Common carotid artery Measurement Ultrasound |