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

Completed

• Conditions: Atherosclerosis
• Interventions: Procedure: transthoracic examination

• Registration Number: NCT00590616
• Lead Sponsor: Creighton University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-10
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-11
• Last Update Posted: 2014-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	transthoracic examination	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Creighton University Medical Center; 🇺🇸 Omaha, Nebraska, United States