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

This study is currently recruiting participants.

Verified March 2013 by Creighton University

Sponsor:

Information provided by (Responsible Party):

Creighton University

ClinicalTrials.gov Identifier:

NCT00590616

First received: December 28, 2007

Last updated: March 28, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 28, 2007

Last Updated Date

March 28, 2013

Start Date ^ICMJE

February 2005

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00590616 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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%.

Condition ^ICMJE

Atherosclerosis

Intervention ^ICMJE

Procedure: transthoracic examination

observational transthoracic examination

Study Group/Cohort (s)

Intervention: Procedure: transthoracic examination

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Completion Date

Not Provided

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Manu Kaushik, MD

402-280-4566

manukaushik@creighton.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00590616

Other Study ID Numbers ^ICMJE

06-14035, 06-14035

Has Data Monitoring Committee

Responsible Party

Creighton University

Study Sponsor ^ICMJE

Creighton University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Manu Kaushik, MD

Creighton University

Information Provided By

Creighton University

Verification Date

March 2013

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

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