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

This study has been completed.
Information provided by (Responsible Party):
Creighton University Identifier:
First received: December 28, 2007
Last updated: August 11, 2014
Last verified: August 2014
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 Intervention
Atherosclerosis Procedure: transthoracic examination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of Clinical Examination in the Noninvasive Prediction of Aortic Atheroma - A Prospective Study

Resource links provided by NLM:

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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:
  • Demonstrate the incremental value of physical exam signs to the history. [ Time Frame: 6 month, 1 and 2 years ]
  • Follow-up on embolic events - transient ischemic attack (TIA), stroke and mortality and effect of medications [ Time Frame: 6 months, 1 and 2 years ]

Enrollment: 125
Study Start Date: February 2005
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Procedure: transthoracic examination
observational transthoracic examination


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Creighton University Identifier: NCT00590616     History of Changes
Other Study ID Numbers: 06-14035
Study First Received: December 28, 2007
Last Updated: August 11, 2014

Keywords provided by Creighton University:
Aortic atheroma

Additional relevant MeSH terms:
Plaque, Atherosclerotic
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical processed this record on September 21, 2017