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

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.
 
ClinicalTrials.gov Identifier: NCT00976053
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : October 31, 2014
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE September 11, 2009
First Posted Date  ICMJE September 14, 2009
Last Update Posted Date October 31, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
Diagnostic failure of SPECT vs PET [ Time Frame: 60 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Procedure: Myocardial perfusion imaging
Randomization assignment to one of SPECT or PET myocardial perfusion imaging
Study Arms  ICMJE
  • Active Comparator: SPECT myocardial perfusion imaging
    Intervention: Procedure: Myocardial perfusion imaging
  • Active Comparator: PET myocardial perfusion imaging
    Intervention: Procedure: Myocardial perfusion imaging
Publications * Patel KK, Al Badarin F, Chan PS, Spertus JA, Courter S, Kennedy KF, Case JA, McGhie AI, Heller GV, Bateman TM. Randomized Comparison of Clinical Effectiveness of Pharmacologic SPECT and PET MPI in Symptomatic CAD Patients. JACC Cardiovasc Imaging. 2019 Sep;12(9):1821-1831. doi: 10.1016/j.jcmg.2019.04.020. Epub 2019 Jul 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2009)
330
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00976053
Other Study ID Numbers  ICMJE 09-307
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Timothy M. Bateman, Aspire Foundation
Study Sponsor  ICMJE Aspire Foundation
Collaborators  ICMJE
  • Blue Cross Blue Shield
  • Cardiovascular Imaging Technologies
  • Saint Luke's Cardiovascular Consultants
  • Mid America Heart Institute
Investigators  ICMJE
Principal Investigator: Timothy M Bateman, M.D. Aspire Foundation
PRS Account Aspire Foundation
Verification Date October 2014

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