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Clinical Trials/NCT00575549
NCT00575549
No Longer Available
Not Applicable

Prospective Analysis and Comparison of Conventional Stress Echocardiograms and Real-Time Myocardial Contrast Stress Echocardiogram; for Bristol-Myers Squibb Medical Imaging: The Definity RT-P During DSE Database

University of Nebraska1 site in 1 countryDecember 18, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Evaluation of Troponin I Levels
Sponsor
University of Nebraska
Locations
1
Status
No Longer Available
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to prospectively analyze and compare conventional stress echocardiograms and real-time myocardial contrast stress echocardiograms; and to determine the effect of contrast agents used during real-time myocardial contrast stress echocardiograms on serum troponin I levels.

Detailed Description

To compare two different stress echocardiograms (conventional Stress echocardiograms or Real-time Myocardial Contrast Stress Echocardiograms) that are in routine clinical use. The information, including the digital images that are collected during the stress tests is used to determine if the usse of specialized imaging techniques and ultrasound contrast can better detect blockage in blood flow to the heart and predict how patients outcome may be affected by this detection of a blockage.

Registry
clinicaltrials.gov
Start Date
December 18, 2007
End Date
TBD
Last Updated
2 years ago
Study Type
Expanded Access
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or female
  • Age \> 19 years
  • Scheduled for a stress echocardiography
  • Are conscious and coherent, and able to communicate effectively with trial personnel
  • For troponin evaluation, only hospitalized patients who had a troponin level drawn in the morning of and prior to stress echocardiogram will be included.

Exclusion Criteria

  • Pregnant and breast feeding women are excluded from participation because of the possibility of a bias as CSE is routinely used in pregnant patients secondary to lack of human studies to determine the fetal risk of use of Definity.
  • Age \< 19 years old
  • Known or suspected hypersensitivity to ultrasound contrast agents or other drugs used for the study
  • Possibility that potential subject may be pregnant
  • Studies where RT-MCE was specifically requested by the ordering physician

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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