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Carotid Atherosclerotic Plaque Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214006
First received: September 13, 2005
Last updated: March 6, 2013
Last verified: March 2013
History of Changes

September 13, 2005
March 6, 2013
November 2001
November 2010   (final data collection date for primary outcome measure)
Lipid protein analysis and cognitive status comparison [ Time Frame: 2008-2011 ] [ Designated as safety issue: No ]

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.
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Complete list of historical versions of study NCT00214006 on ClinicalTrials.gov Archive Site
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Carotid Atherosclerotic Plaque Study
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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients undergoing carotid endarectomy
Atherosclerosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
February 2011
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00214006
2008-0053
No
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Robert J. Dempsey, MD University of Wisconsin, Madison
University of Wisconsin, Madison
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP