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OpenTrials
Completed

NCT Number: NCT00588484

Ultrasound-based Intima-Media Thickness Measurements

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

Completed

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Key information

Conditions

Carotid Artery Intima Media Thickness

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Jan 8, 2008
Registry last updated
Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.