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

NCT ID: NCT00575549

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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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.

Conditions

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Evaluation of Troponin I Levels

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Definity

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas R Porter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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0311-07-FB

Identifier Type: -

Identifier Source: org_study_id

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