Carotid Atherosclerotic Plaque Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

Lipid protein analysis and cognitive status comparison

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start: 2001
Primary completion: 2010
Study completion: 2011
First posted: Sep 21, 2005
Registry last updated: Mar 7, 2013

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.

Published trials that share one or more normalized conditions with this study.

Completed