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Ultrasound-based Intima-Media Thickness Measurements

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588484
First received: December 25, 2007
Last updated: November 7, 2012
Last verified: November 2012
History of Changes

December 25, 2007
November 7, 2012
December 2002
September 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The primary statistical endpoint for this study is to determine the standard deviation and 95% confidence interval of the IMT measurements obtained by utilizing the a certain technique. [ Time Frame: Four years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00588484 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Standard deviation and 95% confidence interval of the IMT measurements from data subsets (only longitudinal clips) judged with average or better image quality. [ Time Frame: Two years ] [ Designated as safety issue: No ]
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Ultrasound-based Intima-Media Thickness Measurements
Determination of the Precision and Clinical Utility of 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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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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.
Carotid Artery Intima Media Thickness
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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.
  • 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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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
35 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588484
2466-02
No
Nicholas J. Hangiandreou, Ph.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Nicholas J. Hangiandreou, Ph.D. Mayo Clinic
Mayo Clinic
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP