Feasibility and Diagnostic Accuracy of Myocardial Perfusion Imaging Using Early Imaging Protocol
| Tracking Information | |||||
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| First Received Date ICMJE | August 14, 2012 | ||||
| Last Updated Date | February 18, 2013 | ||||
| Start Date ICMJE | February 2013 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Feasibility and accuracy of early imaging at 10 minutes (W10) vs. standard imaging at 30-45 minute after radiotracer injection [ Time Frame: 30 days ] [ Designated as safety issue: No ] The feasibility of W10 imaging will be assessed visually using a 3-point scale as well as semiquantitatively using region-of-interest measurements. The accuracy of W10 imaging will be determined by comparing the findings of W10 with those of coronary angiography, which will be obtained within 30 days of the MPI and serve as reference standard. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01700972 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Tolerability of early imaging at 10 minutes (W10) [ Time Frame: Two hours ] [ Designated as safety issue: No ] The tolerability of W10 will be assessed using 3-point scale Questionnaires. |
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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 | Feasibility and Diagnostic Accuracy of Myocardial Perfusion Imaging Using Early Imaging Protocol | ||||
| Official Title ICMJE | Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol: A Pilot Study | ||||
| Brief Summary | The current protocol for myocardial perfusion imaging (MPI) entails imaging within 30-45 minutes after radiotracer injection, for both rest and stress studies. We hypothesize that early imaging 10 minutes after radiotracer injection provides high image quality and diagnostic accuracy comparable to 30-45 minutes MPI. |
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| Detailed Description | The current MPI protocol entails imaging within 30-45 minutes after radiotracer injection (W30 imaging), for both the rest and stress part. This delay between the radiotracer injection and imaging is intended to limit the nonspecific liver and gut radioactivity to the heart and allows an optimal imaging of the heart. A recent publication however indicates that an early imaging within 10 minutes after radiotracer injection (W10 imaging) appears feasible and may be as good as W30 imaging. Encouraged by the recent data, we think that a waiting time of 10 minutes is feasible while preserving the image quality; thus, we would like to assess the feasibility and accuracy of W10 imaging compared with W30 imaging in this study. The main purpose of this study is to obtain imaging information on the use of early imaging (W10). The feasibility of W10 imaging will be assessed visually using a 3-point scale as well as semiquantitatively using region-of-interest measurements. The accuracy of W10 imaging will be determined by comparing the findings of W10 with those of coronary angiography, which will be obtained within 30 days of the MPI and serve as reference standard. The tolerability of W10 will be assessed using 3-point scale Questionnaires. This study will determine if early MPI imaging within 10 minutes works as well as imaging after 30-45 minutes waiting and its role in the diagnosis of coronary artery disease. The major advantages of this new imaging procedure include the shortening of the procedure time, the reduction of patient discomfort and improvement of patient care. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Procedure: Myocardial perfusion imaging
The radionuclide Myoview will be administered once for the rest and stress myocardial perfusion imaging. The subsequent rest and stress imaging will be performed twice each - at 10 minutes and 30-45 minutes after radiotracer injection.
Other Name: Myocardial perfusion SPECT |
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| Study Arm (s) | Experimental: Imaging at 10-minute vs. 30-45-minutes
The radionuclide Myoview will be administered once for the rest and stress myocardial perfusion imaging. The subsequent rest and stress imaging will be performed twice each - at 10 minutes and 30-45 minutes after radiotracer injection.
Intervention: Procedure: Myocardial perfusion imaging |
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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 | 36 | ||||
| Estimated Completion Date | August 2014 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01700972 | ||||
| Other Study ID Numbers ICMJE | REGA-12B03 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | St. Louis University | ||||
| Study Sponsor ICMJE | St. Louis University | ||||
| Collaborators ICMJE | Astellas Pharma US, Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | St. Louis University | ||||
| Verification Date | February 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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