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CompletedNCT00976053Updated Oct 31, 2014

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

A Phase 4 interventional study of Myocardial perfusion imaging in Coronary Artery Disease, sponsored by Aspire Foundation. Completed at 1 site in United States. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-10-31.

Sponsored by Aspire Foundation · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
30 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Coronary Artery Disease

Keywords

  • Myocardial perfusion imaging
  • Single photon emission computed tomography
  • Positron emission tomography
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 330 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Aspire Foundation is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
330 participants (actual)

Study arms

  • Active comparator
    SPECT myocardial perfusion imaging

    Procedure: Myocardial perfusion imaging

  • Active comparator
    PET myocardial perfusion imaging

    Procedure: Myocardial perfusion imaging

Interventions

  • ProcedureMyocardial perfusion imaging

    Randomization assignment to one of SPECT or PET myocardial perfusion imaging

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What researchers measure

Primary outcomes

  1. Diagnostic failure of SPECT vs PET

    Time frame: 60 days

Secondary outcomes

  1. Composite of diagnostic or clinical failure

    Time frame: 12 months

  2. Each of individual components of clinical failure

    Time frame: 12 months

  3. Relative effect on quality of life

    Time frame: 3 months, 6 months

  4. Relative direct and downstream costs

    Time frame: 3 months, 6 months, 12 months

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Study locations

1 site
  • Saint Luke's Cardiovascular Consultants
    Kansas City, Missouri 64111, United States
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References and documents

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. PubMed 31326480 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00976053
Lead sponsor
Aspire Foundation
Collaborators
Blue Cross Blue Shield, Cardiovascular Imaging Technologies, Saint Luke's Cardiovascular Consultants, Mid America Heart Institute
Responsible party
Timothy M. Bateman (Prinicpal Investigator/Medical Director, Aspire Foundation) — Principal investigator
First posted
Sep 14, 2009
Start date
Jun 2009
Primary completion
Sep 2013
Completion
Oct 2014
Last update
Oct 31, 2014

Study contacts

Timothy M Bateman, M.D.
principal investigator · Aspire Foundation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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