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

NCT00590616 | Completed

• 1 other identifier: 06-14035
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Keywords

Aortic atheroma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (1)

1

Procedure: transthoracic examination

Interventions

transthoracic examination PROCEDURE

observational transthoracic examination

1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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%.

You may qualify if:

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

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Manu Kaushik, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 10, 2008
• Study Start: February 1, 2005
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 12, 2014

Record last verified: 2014-08

Locations

US (1)