Ultrasound-based Intima-Media Thickness Measurements

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00588484

Enrollment

128

Registered

2008-01-08

Start date

2002-12-31

Completion date

2009-09-30

Last updated

2012-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Artery Intima Media Thickness

Keywords

Carotid artery, Common carotid artery, Measurement, Ultrasound

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Secondary

Measure	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

Countries

United States

Outcome results