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

January 11, 2010 updated by: Cardiac Imaging of Augusta

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

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?

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Cardiac Imaging of Augusta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred for MPI

Description

Inclusion Criteria:

  • Patients receiving sestamibi MPI study or tetrofosmin MPI study

Exclusion Criteria:

  • Thallium or dual isotope MPI study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of studies repeated.
Time Frame: four weeks
four weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of studies that should have been repeated
Time Frame: two weeks after data collection
two weeks after data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiac Imaging of Augusta

Collaborators

GE Healthcare

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

February 1, 2010

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DB1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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