NCT00590616|Completed
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Sponsor study identifier
Secondary identifiers
observational
125
1 country
1
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)Aortic atheroma has been correlated with traditional cardiac risk factors, coronary, carotid, renal and peripheral atherosclerosis, and is probably a manifestation of generalized atherosclerosis. Aortic atheroma has also been shown to be associated with atrial fibrillation, aortic valve sclerosis, and other calcification of the fibrous skeleton of the heart. None of the previous studies have looked at the noninvasive prediction of aortic atheroma using the history and physical signs of cardiovascular disease. This would be a time and cost-effective bedside diagnostic tool that would be useful prior to cardiac surgery, cardiac catheterization, and workup of ischemic stroke patients, especially when transesophageal echocardiogram (TEE) is being considered for diagnosis but cannot be obtained due to previously mentioned reasons. Although physical examination of peripheral vascular disease is non-specific, a combination of physical examination signs increases the probability of generalized atherosclerosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
December 28, 2007
Actual (reported)January 10, 2008
Actual (reported)July 2014
Actual (reported)July 2014
Actual (reported)Identify clinical predictors of aortic atheromatous disease and develop risk score to identify with reasonable accuracy the presence of any aortic atheromatous disease and severe atheromatous disease (grade 4 & 5).
6 month. 1 year and 2 year
Demonstrate the incremental value of physical exam signs to the history.
6 month, 1 and 2 years
Follow-up on embolic events - transient ischemic attack (TIA), stroke and mortality and effect of medications
6 months, 1 and 2 years
observational transthoracic examination
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All patients referred for TEE examination, since the primary end-point would be diagnosis of aortic atheromatous disease on TEE. Prevalence of aortic atheroma, based on previous data at Creighton and other studies in any aortic atheroma \~50% and severe aortic atheroma \~5%.
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Manu Kaushik, MD
Creighton University
125 participants (actual enrollment reported by the registry).
First Submitted
December 28, 2007
First Posted
January 10, 2008
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
Inflammation and Vascular Function in Atherosclerosis
Contact the study team to confirm eligibility.
Primary Completion
July 2014
Actual (reported)Study Completion
July 2014
Actual (reported)Last Updated
August 12, 2014
Record last verified: 2014-08
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Source: ClinicalTrials.gov.
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