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Carotid Atherosclerotic Plaque Study

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT00214006
Collaborator
(none)
162
Enrollment
1
Location
111
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    162 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Carotid Atherosclerotic Plaque Study
    Study Start Date :
    Nov 1, 2001
    Actual Primary Completion Date :
    Nov 1, 2010
    Actual Study Completion Date :
    Feb 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Wisconsin Madison Wisconsin United States 53792

    Sponsors and Collaborators

    • University of Wisconsin, Madison

    Investigators

    • Principal Investigator: Robert J. Dempsey, MD, University of Wisconsin, Madison

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT00214006
    Other Study ID Numbers:
    • 2008-0053
    First Posted:
    Sep 21, 2005
    Last Update Posted:
    Mar 7, 2013
    Last Verified:
    Mar 1, 2013
    Additional relevant MeSH terms:
    Atherosclerosis
    Plaque, Atherosclerotic

    Study Results

    No Results Posted as of Mar 7, 2013