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Prospective Analysis and Comparison of Stress Echo to Real-Time Myocardial Contrast Stress Echo

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Verified July 2012 by University of Nebraska
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Thomas R. Porter, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00575549
First received: December 14, 2007
Last updated: July 19, 2012
Last verified: July 2012
History of Changes

December 14, 2007
July 19, 2012
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Complete list of historical versions of study NCT00575549 on ClinicalTrials.gov Archive Site
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Prospective Analysis and Comparison of Stress Echo to Real-Time Myocardial Contrast Stress Echo
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

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.

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.
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Evaluation of Troponin I Levels
Other: Dobutamine: Perflutren Lipid Microsphere
Dobutamine with starting dose of 10 micrograms/kg/min and increased gradually to a maximum dose of 50 micrograms/kg/min Definity will be infused continuously at a rate of 4mL/min
Other Name: Definity
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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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
Both
19 Years and older
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Contact: Thomas R Porter, MD 402-559-7977 trporter@unmc.edu
Contact: Stacey Therrien, BS 402-559-7977 stherrien@unmc.edu
United States
 
NCT00575549
311-07-FB
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Thomas R. Porter, MD, University of Nebraska
University of Nebraska
Bristol-Myers Squibb
Principal Investigator: Thomas R Porter, MD UNMC
University of Nebraska
July 2012

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