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

Expanded access is currently available for this treatment.
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
  Purpose

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 Intervention
Evaluation of Troponin I Levels
 Other: Dobutamine: Perflutren Lipid Microsphere

Study Type: Expanded Access     What is 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 NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

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
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575549

Contacts
Contact: Thomas R Porter, MD 402-559-7977 trporter@unmc.edu
Contact: Stacey Therrien, BS 402-559-7977 stherrien@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Contact: Saritha Dodla, MD     402-559-7271     sdodla@unmc.edu    
Contact: Stacey L Kearney, BS     402-559-7977     skearney@unmc.edu    
Sponsors and Collaborators
University of Nebraska
Bristol-Myers Squibb
Investigators
Principal Investigator: Thomas R Porter, MD UNMC
  More Information

No publications provided

Responsible Party: Thomas R. Porter, MD, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT00575549     History of Changes
Other Study ID Numbers: 311-07-FB
Study First Received: December 14, 2007
Last Updated: July 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dobutamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on May 16, 2013