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Clinical Trials/NCT00590616
NCT00590616
Completed
Not Applicable

Utility of Clinical Examination in the Noninvasive Prediction of Aortic Atheroma - A Prospective Study

Creighton University1 site in 1 country125 target enrollmentFebruary 2005
ConditionsAtherosclerosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atherosclerosis
Sponsor
Creighton University
Enrollment
125
Locations
1
Primary Endpoint
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).
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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
clinicaltrials.gov
Start Date
February 2005
End Date
July 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All consecutive patients who are referred for transesophageal echocardiography (TEE) since the primary endpoint is diagnosis of aortic atheroma on TEE

Exclusion Criteria

  • No exclusion after consent for TEE is obtained. Decision not to perform TEE at the discretion of treating physician

Outcomes

Primary Outcomes

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).

Time Frame: 6 month. 1 year and 2 year

Secondary Outcomes

  • 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)

Study Sites (1)

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