Rapid Stress/Rest Single-Day Tc-99m Sestamibi Myocardial Single Photon Emission Computed Tomography
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|ClinicalTrials.gov Identifier: NCT01434641|
Recruitment Status : Completed
First Posted : September 15, 2011
Results First Posted : April 11, 2016
Last Update Posted : April 11, 2016
This protocol details a novel myocardial perfusion Single Photon Emission Computed Tomography (SPECT) protocol wherein patients receive a low-dose (6 mCi) of Tc-99m sestamibi during exercise or regadenoson pharmacologic stress and undergo a full-time SPECT acquisition processed with Wide Beam Reconstruction (WBR). Immediately thereafter patients receive a high-dose (30-35 mCi) of Tc-99m sestamibi at rest and undergo a half-time rest scan, also processed with WBR. All enrolled research subjects will undergo both the initial stress and subsequent rest scan.
The radiation exposure associated with this new stress/rest protocol is equivalent to that of the conventional rest/stress protocol presently in routine clinical uses at SLRHC.
Eventually, when and if this novel stress/rest protocol is adopted in routine clinical practice, patients with normal stress scans would receive only 6 mCi of Tc-99m sestamibi (331 mSv in men, 241 mSv in women) and spend only approximately one hour in the Nuclear Medicine Laboratory.
All patients presenting to the Nuclear Medicine Laboratory for evaluation of known or suspected coronary artery disease will be candidates for enrollment. Fifty patients undergoing treadmill exercise stress and 50 patients undergoing regadenoson pharmacologic stress will be enrolled. Pregnant and breast-feeding patients will not be eligible.
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Other: low-dose stress MPI SPECT|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rapid Stress/Rest Single-Day Tc-99m Sestamibi Myocardial SPECT|
|Study Start Date :||July 2011|
|Primary Completion Date :||March 2012|
|Study Completion Date :||March 2012|
low-dose stress MPI SPECT
Patients will receive a low-dose stress/high-dose rest protocol. Subject results are compared to archived patients undergoing a standard protocol./
Other: low-dose stress MPI SPECT
novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
- Myocardial Perfusion SPECT Image Quality 12 Minutes [ Time Frame: at 12 minutes ]SPECT image quality realized using the stress/rest single-day protocol: 12- minute post-stress acquisitions If myocardial image quality is equivalent or superior to that encountered with standard myocardial perfusion SPECT performed using a standard low-dose rest/high-dose SPECT protocol and OSEM processing and if the rest/stress myocardial count density ratio is > 3.5 the outcome of a particular patient is judged to be favorable (acceptable).If either image quality is "poor" or if the rest/stress count density ratio is less than 3.5, the outcome is judged unfavorable.
- Myocardial Perfusion SPECT Image Quality 16 Minutes [ Time Frame: at 16 minutes ]SPECT image quality realized using the stress/rest single-day protocol: 16- minute post-stress acquisitions If myocardial image quality is equivalent or superior to that encountered with standard myocardial perfusion SPECT performed using a standard low-dose rest/high-dose SPECT protocol and OSEM processing and if the rest/stress myocardial count density ratio is > 3.5 the outcome of a particular patient is judged to be favorable (acceptable).If either image quality is "poor" or if the rest/stress count density ratio is less than 3.5, the outcome is judged unfavorable.
- Rest/Stress Myocardial Count Density Ratio [ Time Frame: immediately following SPECT image processing (1 hour after the test) ]
The rest and stress myocardial count densities are determined automatically using Evolution software on the GE Healthcare Xeleris Nuclear Medicine computer workstation. The ratio is calculated by simple division.
Please not that patient outcomes are NOT measured in this research protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434641
|United States, New York|
|`St. Luke's-Roosevelt Hospital|
|New York, New York, United States, 10025|
|Principal Investigator:||Ernest G DePuey, M.D.||St. Luke's-Roosevelt Hospital Center|