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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Cardiac Imaging of Augusta.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
GE Healthcare
Information provided by:
Cardiac Imaging of Augusta
ClinicalTrials.gov Identifier:
NCT01047150
First received: January 11, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Cardiac Imaging of Augusta:

Primary Outcome Measures:
  • Number of studies repeated. [ Time Frame: four weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Study Population

Patients referred for MPI

Criteria

Inclusion Criteria:

  • Patients receiving sestamibi MPI study or tetrofosmin MPI study

Exclusion Criteria:

  • Thallium or dual isotope MPI study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047150

Contacts
Contact: Danny A Basso, CNMT 7067243926 dbasso@knology.net

Locations
United States, Georgia
Cardiac Imaging of Augusta Completed
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
  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
Technetium Tc 99m Sestamibi
Technetium Tc 99m 1,2-bis(bis(2-ethoxyethyl)phosphino)ethane
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014