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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)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00976053
Enrollment
330
Registered
2009-09-14
Start date
2009-06-30
Completion date
2014-10-31
Last updated
2014-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Myocardial perfusion imaging, Single photon emission computed tomography, Positron emission tomography

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.

Interventions

PROCEDUREMyocardial perfusion imaging

Randomization assignment to one of SPECT or PET myocardial perfusion imaging

Sponsors

Blue Cross Blue Shield
CollaboratorOTHER
Cardiovascular Imaging Technologies
CollaboratorINDUSTRY
Saint Luke's Cardiovascular Consultants
CollaboratorOTHER
Mid America Heart Institute
CollaboratorOTHER
Aspire Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Diagnostic failure of SPECT vs PET60 days

Secondary

MeasureTime frame
Composite of diagnostic or clinical failure12 months
Each of individual components of clinical failure12 months
Relative effect on quality of life3 months, 6 months
Relative direct and downstream costs3 months, 6 months, 12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026