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

Myocardial Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01047150
• Other study ID #: DB1
• Status: Not yet recruiting
• Phase: N/A
• First received: January 11, 2010
• Last updated: January 11, 2010
• Start date: January 2010
• Est. completion date: February 2010

Study information

• Verified date: December 2009
• Source: Cardiac Imaging of Augusta
• Contact: Danny A Basso, CNMT
• Phone: 7067243926
• Email: dbasso[@]knology.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients receiving sestamibi MPI study or tetrofosmin MPI study

Exclusion Criteria:

• Thallium or dual isotope MPI study

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Cardiac Imaging of Augusta	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Cardiac Imaging of Augusta	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of studies repeated.		four weeks	No
Secondary	Number of studies that should have been repeated		two weeks after data collection	No