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

NCT ID: NCT01047150

Last Updated: 2010-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-02-28

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?

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Tetrofosmin Rest patients

Patients that had a Rest myocardial perfusion study using Tc99m tetrofosmin

No interventions assigned to this group

Sestamibi stress patients

Patients that had a stress myocardial perfusion imaging study using Tc99m Sestamibi

No interventions assigned to this group

Tetrofosmin stress patients

Patients that had a stress myocardial perfusion imaging study using Tc99m Tetrofosmin

No interventions assigned to this group

Sestamibi rest patients

Patients that had a rest myocardial perfusion imaging study using Tc99m Sestamibi

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients receiving sestamibi MPI study or tetrofosmin MPI study

Exclusion Criteria

• Thallium or dual isotope MPI study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Cardiac Imaging of Augusta

OTHER

Sponsor Role: lead

Responsible Party

Cardiac Imaging of Augusta

Principal Investigators

Danny A Basso, CNMT

Role: STUDY_DIRECTOR

Cardiac Imaging of Augusta

Locations

Cardiac Imaging of Augusta

Augusta, Georgia, United States

Countries

United States

Central Contacts

Danny A Basso, CNMT

Role: CONTACT

dbasso@knology.net

7067243926

Other Identifiers

DB1

Identifier Type: -

Identifier Source: org_study_id