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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00590616
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : August 12, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Atherosclerosis Procedure: transthoracic examination

Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of Clinical Examination in the Noninvasive Prediction of Aortic Atheroma - A Prospective Study
Study Start Date : February 2005
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
1 Procedure: transthoracic examination
observational transthoracic examination

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00590616

United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Principal Investigator: Manu Kaushik, MD Creighton University

Responsible Party: Creighton University Identifier: NCT00590616     History of Changes
Other Study ID Numbers: 06-14035
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014

Keywords provided by Creighton University:
Aortic atheroma

Additional relevant MeSH terms:
Plaque, Atherosclerotic
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical