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

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ClinicalTrials.gov Identifier: NCT00575549
Expanded Access Status : No longer available
First Posted : December 18, 2007
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Thomas R. Porter, MD, University of Nebraska

Study Description
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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.

Condition or disease Intervention/treatment
Evaluation of Troponin I Levels Other: Dobutamine: Perflutren Lipid Microsphere

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.

Study Design
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Study Type : Expanded Access
Official Title: 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

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • 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
Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575549


Locations
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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Bristol-Myers Squibb
Investigators
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Principal Investigator: Thomas R Porter, MD UNMC
More Information
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Responsible Party: Thomas R. Porter, MD, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT00575549     History of Changes
Other Study ID Numbers: 311-07-FB
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Dobutamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
 Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents