Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Myocardial perfusion imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Myocardial perfusion imaging, Single photon emission computed tomography, Positron emission tomography
Eligibility Criteria
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
Sites / Locations
- Saint Luke's Cardiovascular Consultants
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
SPECT myocardial perfusion imaging
PET myocardial perfusion imaging
Arm Description
Outcomes
Primary Outcome Measures
Diagnostic failure of SPECT vs PET
Secondary Outcome Measures
Composite of diagnostic or clinical failure
Each of individual components of clinical failure
Relative effect on quality of life
Relative direct and downstream costs
Full Information
NCT ID
NCT00976053
First Posted
September 11, 2009
Last Updated
October 30, 2014
Sponsor
Aspire Foundation
Collaborators
Blue Cross Blue Shield, Cardiovascular Imaging Technologies, Saint Luke's Cardiovascular Consultants, Mid America Heart Institute
1. Study Identification
Unique Protocol Identification Number
NCT00976053
Brief Title
Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aspire Foundation
Collaborators
Blue Cross Blue Shield, Cardiovascular Imaging Technologies, Saint Luke's Cardiovascular Consultants, Mid America Heart Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Myocardial perfusion imaging, Single photon emission computed tomography, Positron emission tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPECT myocardial perfusion imaging
Arm Type
Active Comparator
Arm Title
PET myocardial perfusion imaging
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Myocardial perfusion imaging
Intervention Description
Randomization assignment to one of SPECT or PET myocardial perfusion imaging
Primary Outcome Measure Information:
Title
Diagnostic failure of SPECT vs PET
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Composite of diagnostic or clinical failure
Time Frame
12 months
Title
Each of individual components of clinical failure
Time Frame
12 months
Title
Relative effect on quality of life
Time Frame
3 months, 6 months
Title
Relative direct and downstream costs
Time Frame
3 months, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy M Bateman, M.D.
Organizational Affiliation
Aspire Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Luke's Cardiovascular Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31326480
Citation
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.
Results Reference
derived
Learn more about this trial
Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging
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