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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Nebraska.
Recruitment status was  Available
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
  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:


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
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: 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:
Definity
Dobutamine
Perflutren
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Contrast Media
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014