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

This study is currently recruiting participants.
Verified November 2013 by Aspire Foundation
Sponsor:
Collaborators:
BlueCross BlueShield of Kansas City
Cardiovascular Imaging Technologies
Saint Luke's Cardiovascular Consultants
Mid America Heart Institute
Information provided by (Responsible Party):
Staci Courter, MA, Aspire Foundation
ClinicalTrials.gov Identifier:
NCT00976053
First received: September 11, 2009
Last updated: November 20, 2013
Last verified: November 2013

September 11, 2009
November 20, 2013
June 2009
September 2013   (final data collection date for primary outcome measure)
Diagnostic failure of SPECT vs PET [ Time Frame: 60 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Each of individual components of clinical failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Relative effect on quality of life [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]
  • Relative direct and downstream costs [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Symptomatic 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.
 
Recruiting
330
September 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
Both
30 Years to 90 Years
No
Contact: Timothy M Bateman, M.D. 816-751-8542 tbateman@cc-pc.com
Contact: Staci A Courter, M.A. 816-531-2842 ext 107 scourter@cvit.com
United States
 
NCT00976053
09-307
Yes
Staci Courter, MA, Aspire Foundation
Aspire Foundation
  • BlueCross BlueShield of Kansas City
  • Cardiovascular Imaging Technologies
  • Saint Luke's Cardiovascular Consultants
  • Mid America Heart Institute
Principal Investigator: Timothy M Bateman, M.D. Aspire Foundation
Aspire Foundation
November 2013

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