Evaluation of Troponin I LevelsNCT00575549
Prospective Analysis and Comparison of Stress Echo to Real-Time Myocardial Contrast Stress Echo
A study testing Dobutamine: Perflutren Lipid Microsphere in people with Evaluation of Troponin I Levels, run by University of Nebraska at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Evaluation of Troponin I Levels
- What is being tested?
- Dobutamine: Perflutren Lipid Microsphere
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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
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.
Read the 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.
- Conditions
- Evaluation of Troponin I Levels
- Being tested
- Dobutamine: Perflutren Lipid Microsphere
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dobutamine: Perflutren Lipid MicrosphereOther
Also called Definity
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Troponin I LevelsStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Thomas R Porter, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575549
- Sponsor's protocol ID
- 0311-07-FB
- Status last verified
- Oct 2023
- First submitted
- 14 Dec 2007
- Last updated
- 13 Oct 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00575549
- Acronym / sponsor ID
- 0311-07-FB
- Conditions
- Evaluation of Troponin I Levels
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- First posted
- 18 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dobutamine: Perflutren Lipid MicrosphereAlso: DefinityDobutamine 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 | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas R Porter, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dobutamine: Perflutren Lipid Microsphere in people with Evaluation of Troponin I Levels, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.