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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
  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.


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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%.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590616

Locations
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Manu Kaushik, MD Creighton University
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00590616     History of Changes
Other Study ID Numbers: 06-14035, 06-14035
Study First Received: December 28, 2007
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Aortic atheroma

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014