Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging
October 30, 2014 updated by: Timothy M. Bateman, Aspire Foundation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
330
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64111
- Saint Luke's Cardiovascular Consultants
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: SPECT myocardial perfusion imaging
|
Randomization assignment to one of SPECT or PET myocardial perfusion imaging
|
|
Active Comparator: PET myocardial perfusion imaging
|
Randomization assignment to one of SPECT or PET myocardial perfusion imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Diagnostic failure of SPECT vs PET
Time Frame: 60 days
|
60 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Composite of diagnostic or clinical failure
Time Frame: 12 months
|
12 months
|
|
Each of individual components of clinical failure
Time Frame: 12 months
|
12 months
|
|
Relative effect on quality of life
Time Frame: 3 months, 6 months
|
3 months, 6 months
|
|
Relative direct and downstream costs
Time Frame: 3 months, 6 months, 12 months
|
3 months, 6 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Timothy M Bateman, M.D., Aspire Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
September 11, 2009
First Submitted That Met QC Criteria
September 11, 2009
First Posted (Estimate)
September 14, 2009
Study Record Updates
Last Update Posted (Estimate)
October 31, 2014
Last Update Submitted That Met QC Criteria
October 30, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-307
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.