Carotid Atherosclerotic Plaque Study

Completed

• Conditions: Atherosclerosis

• Registration Number: NCT00214006
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

First, to establish a comparison of the pathophysiology of carotid atherosclerosis and the genetic and environmental variables that cause those plaques to become symptomatic. Second, to differentiate between vulnerable plaque and other types of plaque using ultrasound elastography, MRI data, trans-cranial doppler along with RF (radio frequency) analysis of back-scattered ultrasonic echoes.

Detailed Description

This is a multi-investigator study based on the pathophysiology of carotid atherosclerosis and the variables that cause certain plaques to become symptomatic.Patients enrolled in this study will be those patients undergoing a carotid endarterectomy. This will include both symptomatic and asymptomatic patients, and there are a variety of atherosclerotic risk factors representing this patient population.Patients may or may not have had strokes or transient ischemic attacks (TIAs).Pre-operatively patients will be reviewed for their medical history and atherosclerotic risk factors. Plaque removed during routine carotid endarterectomy will be examined for study purposes.

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2010-11
• Study Completion: 2011-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-06
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• Male and Female patients aged 18-80 presenting for carotid endarterectomy

Exclusion Criteria

• Patients not felt suitable for carotid endarterectomy and those with impaired decision-making capacity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lipid protein analysis and cognitive status comparison	2008-2011	Comparison studies will be done using the lipid protein analysis and imaging studies. The primary comparison will be between those that are symptomatic and those that are asymptomatic. Secondary comparisons will be done using the lipid protein analysis and patient history.; Comparison of cognitive status between groups will be made using analysis of covariance in which the difference in follow-up score between groups (symptomatic/asymptomatic) is adjusted for baseline score. The baseline adjusted standard error is 6.4, which with 36 subjects per group will yield 90% power to detect a difference between groups of approximately 4.9 points at a significant level of 5%. We need 36 subjects per group to achieve the power stated. We have built in another 15% for projected dropout to insure we meet the final target.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States