Determination of the Precision and Clinical Utility of Ultrasound-based Intima-Media Thickness Measurements

Mayo Clinic1 site in 1 country128 target enrollmentDecember 2002

ConditionsCarotid Artery Intima Media Thickness

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carotid Artery Intima Media Thickness
Sponsor: Mayo Clinic
Enrollment: 128
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Develop a standard technique and demonstrate adequate precision for measurement of intima-media thickness (IMT) for routine clinical use.

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.

Registry

clinicaltrials.gov

Start Date

December 2002

End Date

September 2009

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Mayo Clinic

Eligibility Criteria

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.

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.(Two years)