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Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976053
First Posted: September 14, 2009
Last Update Posted: October 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Blue Cross Blue Shield
Cardiovascular Imaging Technologies
Saint Luke's Cardiovascular Consultants
Mid America Heart Institute
Information provided by (Responsible Party):
Timothy M. Bateman, Aspire Foundation
September 11, 2009
September 14, 2009
October 31, 2014
June 2009
September 2013   (Final data collection date for primary outcome measure)
Diagnostic failure of SPECT vs PET [ Time Frame: 60 days ]
Same as current
Complete list of historical versions of study NCT00976053 on ClinicalTrials.gov Archive Site
  • Composite of diagnostic or clinical failure [ Time Frame: 12 months ]
  • Each of individual components of clinical failure [ Time Frame: 12 months ]
  • Relative effect on quality of life [ Time Frame: 3 months, 6 months ]
  • Relative direct and downstream costs [ Time Frame: 3 months, 6 months, 12 months ]
Same as current
Not Provided
Not Provided
 
Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging
Clinical Effectiveness of Pharmacologic Stress Radionuclide Myocardial Perfusion Imaging as a Guide to Management of Patients With Known CAD: Comparison of Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET)
The purpose of this study is to compare pharmacologic stress myocardial perfusion PET with pharmacologic stress myocardial perfusion SPECT in a near-simultaneous, head-to-head comparison in the same patient. The investigators hypothesize that pharmacologic stress myocardial perfusion PET will prove superior to pharmacologic stress myocardial perfusion SPECT as a first-line diagnostic test for higher-risk patients with known coronary artery disease (CAD) who present with symptoms consistent with possible worsening of their CAD.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Coronary Artery Disease
Procedure: Myocardial perfusion imaging
Randomization assignment to one of SPECT or PET myocardial perfusion imaging
  • Active Comparator: SPECT myocardial perfusion imaging
    Intervention: Procedure: Myocardial perfusion imaging
  • Active Comparator: PET myocardial perfusion imaging
    Intervention: Procedure: Myocardial perfusion imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
October 2014
September 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of coronary artery disease
  • New or worsening symptoms
  • Out-patients and in-hospital patients

Exclusion Criteria:

  • Creatinine above 2.5 mg%
  • PCI within prior 6 months
  • Pregnant females
  • Cardiomyopathy (LVEF below 40%)
  • Significant valvular heart disease
  • Body mass index greater than 38
Sexes Eligible for Study: All
30 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00976053
09-307
Yes
Not Provided
Not Provided
Timothy M. Bateman, Aspire Foundation
Aspire Foundation
  • Blue Cross Blue Shield
  • Cardiovascular Imaging Technologies
  • Saint Luke's Cardiovascular Consultants
  • Mid America Heart Institute
Principal Investigator: Timothy M Bateman, M.D. Aspire Foundation
Aspire Foundation
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP