COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Carotid Atherosclerotic Plaque Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00214006
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 7, 2013
Information provided by (Responsible Party):
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.

Condition or disease

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 162 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Carotid Atherosclerotic Plaque Study
Study Start Date : November 2001
Actual Primary Completion Date : November 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing carotid endarectomy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00214006

Layout table for location information
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Layout table for investigator information
Principal Investigator: Robert J. Dempsey, MD University of Wisconsin, Madison
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison Identifier: NCT00214006    
Other Study ID Numbers: 2008-0053
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Plaque, Atherosclerotic
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical