The Comparison of the Necessity of Repeat Myocardial Perfusion SPECT Studies Between Tc-99m Tetro and Tc-99m Mibi

Sponsor
Cardiac Imaging of Augusta (Other)
Overall Status
Unknown status
CT.gov ID
NCT01047150
Collaborator
GE Healthcare (Industry)
250
1
1
245.5

Study Details

Study Description

Brief 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 technologist reviewer blinded to the radiopharmaceutical makes the decision to repeat the study?

  3. Is there a significant difference in the quantitative diagnostic measures reported between the original and the acceptable repeated studies?

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    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
    Study Start Date :
    Jan 1, 2010
    Anticipated Primary Completion Date :
    Feb 1, 2010
    Anticipated Study Completion Date :
    Feb 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Number of studies repeated. [four weeks]

    Secondary Outcome Measures

    1. Number of studies that should have been repeated [two weeks after data collection]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients receiving sestamibi MPI study or tetrofosmin MPI study
    Exclusion Criteria:
    • Thallium or dual isotope MPI study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardiac Imaging of Augusta Augusta Georgia United States 30901

    Sponsors and Collaborators

    • Cardiac Imaging of Augusta
    • GE Healthcare

    Investigators

    • Study Director: Danny A Basso, CNMT, Cardiac Imaging of Augusta

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01047150
    Other Study ID Numbers:
    • DB1
    First Posted:
    Jan 12, 2010
    Last Update Posted:
    Jan 12, 2010
    Last Verified:
    Dec 1, 2009
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 12, 2010