Expired Study
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Omaha, Nebraska 68131


Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

06-14035


NCT ID:

NCT00590616


Secondary ID:

06-14035


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Creighton University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

125


Enrollment Type:

Actual


Overall Contact Information

Official Name:Manu Kaushik, MD
Principal Investigator
Creighton University

Study Dates

Start Date:February 2005
Completion Date:July 2014
Completion Type:Actual
Primary Completion Date:July 2014
Primary Completion Type:Actual
Verification Date:August 2014
Last Changed Date:August 11, 2014
First Received Date:December 28, 2007

Study Outcomes

Outcome Type: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Demonstrate the incremental value of physical exam signs to the history.
Time Frame:6 month, 1 and 2 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Follow-up on embolic events - transient ischemic attack (TIA), stroke and mortality and effect of medications
Time Frame:6 months, 1 and 2 years
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:transthoracic examination
Description:observational transthoracic examination
Arm Name:1

Study Arms

Study Arm Type:Other
Arm Name:1

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Creighton University

Samples and Retentions

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%.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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