Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging
This study is currently recruiting participants.
Verified May 2013 by Aspire Foundation
Sponsor:
Aspire Foundation
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: May 6, 2013
Last verified: May 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 11, 2009 | ||||||||
| Last Updated Date | May 6, 2013 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Diagnostic failure of SPECT vs PET [ Time Frame: 60 days ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00976053 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effectiveness Study of Single Photon Emission Computed Tomography (SPECT) Versus Positron Emission Tomography (PET) Myocardial Perfusion Imaging | ||||||||
| Official Title ICMJE | 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) | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Symptomatic Coronary Artery Disease | ||||||||
| Intervention ICMJE | Procedure: Myocardial perfusion imaging
Randomization assignment to one of SPECT or PET myocardial perfusion imaging |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 330 | ||||||||
| Estimated Completion Date | June 2014 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 30 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00976053 | ||||||||
| Other Study ID Numbers ICMJE | 09-307 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Staci Courter, MA, Aspire Foundation | ||||||||
| Study Sponsor ICMJE | Aspire Foundation | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Aspire Foundation | ||||||||
| Verification Date | May 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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