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

Evaluation of Troponin I Levels Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00575549
• Other study ID #: 0311-07-FB
• Status: No longer available

Study information

• Verified date: October 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Evaluation of Troponin I Levels

Intervention

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

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Bristol-Myers Squibb

Country where clinical trial is conducted

United States,