Ultrasound-based Intima-Media Thickness Measurements

Mayo Clinic

Status: Completed

Conditions: Carotid Artery Intima Media Thickness

Study type: Observational

Funder types: Other

Identifiers

NCT00588484

2466-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

128 participants in 2 patient groups

1

Description:

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

Description:

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.