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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis
• Intervention / Treatment: Procedure: transthoracic examination

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Creighton University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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%.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1	Procedure: transthoracic examination; observational transthoracic examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	6 month. 1 year and 2 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Creighton University
• Investigators: Principal Investigator: Manu Kaushik, MD, Creighton University

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: January 9, 2008
• First Posted (Estimate): January 10, 2008

Study Record Updates

• Last Update Posted (Estimate): August 12, 2014
• Last Update Submitted That Met QC Criteria: August 11, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Aortic atheroma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Atherosclerosis; Plaque, Atherosclerotic
• Other Study ID Numbers: 06-14035