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OpenTrials
Completed

NCT Number: NCT00590616

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transthoracic examination

Procedure

observational transthoracic examination

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).

    Time frame: 6 month. 1 year and 2 year

Secondary outcomes

  1. Demonstrate the incremental value of physical exam signs to the history.

    Time frame: 6 month, 1 and 2 years

  2. Follow-up on embolic events - transient ischemic attack (TIA), stroke and mortality and effect of medications

    Time frame: 6 months, 1 and 2 years

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Jan 10, 2008
Registry last updated
Aug 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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