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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590616
• Other study ID #: 06-14035
• Secondary ID: 06-14035
• Status: Completed
• Phase: N/A
• First received: December 28, 2007
• Last updated: August 11, 2014
• Start date: February 2005
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Procedure:
• transthoracic examination
observational transthoracic examination

Locations

Country	Name	City	State
United States	Creighton University Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Demonstrate the incremental value of physical exam signs to the history.		6 month, 1 and 2 years	No
Secondary	Follow-up on embolic events - transient ischemic attack (TIA), stroke and mortality and effect of medications		6 months, 1 and 2 years	No