Ultrasound-based Intima-Media Thickness Measurements

Mayo Clinic128 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

128

Conditions

Carotid Artery Intima Media Thickness

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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