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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00590616
First received: December 28, 2007
Last updated: August 11, 2014
Last verified: August 2014

December 28, 2007
August 11, 2014
February 2005
July 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00590616 on ClinicalTrials.gov Archive Site
  • Demonstrate the incremental value of physical exam signs to the history. [ Time Frame: 6 month, 1 and 2 years ] [ Designated as safety issue: No ]
  • Follow-up on embolic events - transient ischemic attack (TIA), stroke and mortality and effect of medications [ Time Frame: 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
  • Demonstrate the incremental value of physical exam signs to the history. [ Time Frame: 6 month, 1 and 2 years ] [ Designated as safety issue: No ]
  • Follow-up on embolic events- transient ischemic attack (TIA), stroke and mortality and effect of medications [ Time Frame: 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Utility of Clinical Examination in the Noninvasive Prediction of Aortic Atheroma - A Prospective Study
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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%.

Atherosclerosis
Procedure: transthoracic examination
observational transthoracic examination
1
Intervention: Procedure: transthoracic examination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00590616
06-14035, 06-14035
No
Creighton University
Creighton University
Not Provided
Principal Investigator: Manu Kaushik, MD Creighton University
Creighton University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP