Myocardial IschemiaNCT01047150
The Comparison of the Necessity of Repeat Myocardial Perfusion SPECT Studies Between Tc-99m Tetro and Tc-99m Mibi
An observational study of Myocardial Ischemia, run by Cardiac Imaging of Augusta at 1 site in United States.
Trial summary
Research Questions: 1. Is there a significant difference between the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi? 2. Is there a significant difference in the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi if an independent… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Ischemia
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2010
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred for MPI
Who may be able to join
- Patients receiving sestamibi MPI study or tetrofosmin MPI study
Who cannot join
- Thallium or dual isotope MPI study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of the Necessity of Repeat Myocardial Perfusion SPECT Studies Between Tc-99m Tetrofosmin and Tc-99m Sestamibi
Research Questions:
- Is there a significant difference between the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi?
- Is there a significant difference in the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi if an independent technologist reviewer blinded to the radiopharmaceutical makes the decision to repeat the study?
- Is there a significant difference in the quantitative diagnostic measures reported between the original and the acceptable repeated studies?
Read the detailed description
There are two commonly used Tc-99m based radiopharmaceuticals useful in the diagnosis and localization of regions of reversible myocardial ischemia in the presence or absence of infarction under exercise and rest conditions. One is Tc-99m tetrofosmin (Tc-99m-1,2-bis[bis(2-ethoxyethyl) phosphino] ethane), the other is Tc-99m sestamibi (Tc-99m- methoxyisobutylisonitrile). When performing a myocardial perfusion SPECT (MPS) study, extracardiac subdiaphragmatic activity adjacent to the myocardium can cause artifacts in the inferior wall and can be detrimental to the accuracy of the study1,2. Following acquisition, MPS studies are routinely checked for potential imaging artifacts. When a separation between the extracardiac activity cannot clearly be distinguished from the myocardium, the study should be repeated. Repeating the SPECT study can affect the efficiency of a lab as well as having a negative influence on patient comfort and overall satisfaction. The goal of this study is to determine if there is a significant difference in the number of studies that should be repeated between the two commonly used radiopharmaceuticals.
- Conditions
- Myocardial Ischemia
- Keywords
- Myocardial Perfusion Imaging, Repeat studies, Tetrofosmin, Sestamibi
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tetrofosmin Rest patients | Patients that had a Rest myocardial perfusion study using Tc99m tetrofosmin | |
| Sestamibi stress patients | Patients that had a stress myocardial perfusion imaging study using Tc99m Sestamibi | |
| Tetrofosmin stress patients | Patients that had a stress myocardial perfusion imaging study using Tc99m Tetrofosmin | |
| Sestamibi rest patients | Patients that had a rest myocardial perfusion imaging study using Tc99m Sestamibi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of studies repeated.
Measured: four weeks
Secondary outcomes (1)
Number of studies that should have been repeated
Measured: two weeks after data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2010 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiac Imaging of Augusta
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Investigators
- Danny A Basso, CNMT, Study director, Cardiac Imaging of Augusta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047150
- Sponsor's protocol ID
- DB1
- Status last verified
- Dec 2009
- First submitted
- 11 Jan 2010
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Necessity of Repeat Myocardial Perfusion SPECT Studies Between Tc-99m Tetrofosmin and Tc-99m Sestamibi
- ClinicalTrials.gov ID
- NCT01047150
- Acronym / sponsor ID
- DB1
- Conditions
- Myocardial Ischemia
- Keywords
- Myocardial Perfusion Imaging, Repeat studies, Tetrofosmin, Sestamibi
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cardiac Imaging of AugustaUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Jan 2010
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 12 Jan 2010 (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.
Research Questions:
- Is there a significant difference between the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi?
- Is there a significant difference in the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi if an independent technologist reviewer blinded to the radiopharmaceutical makes the decision to repeat the study?
- Is there a significant difference in the quantitative diagnostic measures reported between the original and the acceptable repeated studies?
Detailed description
There are two commonly used Tc-99m based radiopharmaceuticals useful in the diagnosis and localization of regions of reversible myocardial ischemia in the presence or absence of infarction under exercise and rest conditions. One is Tc-99m tetrofosmin (Tc-99m-1,2-bis[bis(2-ethoxyethyl) phosphino] ethane), the other is Tc-99m sestamibi (Tc-99m- methoxyisobutylisonitrile). When performing a myocardial perfusion SPECT (MPS) study, extracardiac subdiaphragmatic activity adjacent to the myocardium can cause artifacts in the inferior wall and can be detrimental to the accuracy of the study1,2. Following acquisition, MPS studies are routinely checked for potential imaging artifacts. When a separation between the extracardiac activity cannot clearly be distinguished from the myocardium, the study should be repeated. Repeating the SPECT study can affect the efficiency of a lab as well as having a negative influence on patient comfort and overall satisfaction. The goal of this study is to determine if there is a significant difference in the number of studies that should be repeated between the two commonly used radiopharmaceuticals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tetrofosmin Rest patients | – | –Patients that had a Rest myocardial perfusion study using Tc99m tetrofosmin |
| Sestamibi stress patients | – | –Patients that had a stress myocardial perfusion imaging study using Tc99m Sestamibi |
| Tetrofosmin stress patients | – | –Patients that had a stress myocardial perfusion imaging study using Tc99m Tetrofosmin |
| Sestamibi rest patients | – | –Patients that had a rest myocardial perfusion imaging study using Tc99m Sestamibi |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred for MPI
Key inclusion criteria (1 listed)
- Patients receiving sestamibi MPI study or tetrofosmin MPI study
Key exclusion criteria (1 listed)
- Thallium or dual isotope MPI study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of studies repeated.
Time frame: four weeks
1 secondary outcome
Number of studies that should have been repeated
Time frame: two weeks after data collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
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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.
Danny A Basso, CNMT study director
Cardiac Imaging of Augusta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia, run by Cardiac Imaging of Augusta 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 1 inclusion and 1 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 12 Jan 2010. 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?
Contact Danny A Basso, CNMT (7067243926, dbasso@knology.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of studies repeated. (time frame: four weeks). It is what the study was designed to measure, not a finding.
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 12 Jan 2010.