The Comparison of the Necessity of Repeat Myocardial Perfusion SPECT Studies Between Tc-99m Tetro and Tc-99m Mibi
Recruitment status was Not yet recruiting
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Purpose
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?
| Condition |
|---|
|
Myocardial Ischemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | The Comparison of the Necessity of Repeat Myocardial Perfusion SPECT Studies Between Tc-99m Tetrofosmin and Tc-99m Sestamibi |
- Number of studies repeated. [ Time Frame: four weeks ] [ Designated as safety issue: No ]
- Number of studies that should have been repeated [ Time Frame: two weeks after data collection ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients referred for MPI
Inclusion Criteria:
- Patients receiving sestamibi MPI study or tetrofosmin MPI study
Exclusion Criteria:
- Thallium or dual isotope MPI study
Contacts and Locations| Contact: Danny A Basso, CNMT | 7067243926 | dbasso@knology.net |
| United States, Georgia | |
| Cardiac Imaging of Augusta | Completed |
| Augusta, Georgia, United States, 30901 | |
| Study Director: | Danny A Basso, CNMT | Cardiac Imaging of Augusta |
More Information
No publications provided
| Responsible Party: | Gordon Leslie Walters, MD, Cardiac Imaging of Augusta |
| ClinicalTrials.gov Identifier: | NCT01047150 History of Changes |
| Other Study ID Numbers: | DB1 |
| Study First Received: | January 11, 2010 |
| Last Updated: | January 11, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cardiac Imaging of Augusta:
|
Myocardial Perfusion Imaging Repeat studies Tetrofosmin Sestamibi |
Additional relevant MeSH terms:
|
Myocardial Ischemia Coronary Artery Disease Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013