Trial Outcomes & Findings for Multi-Center Evaluation of Feasibility of SPECT Measurement of Myocardial Blood Flow and Reserve (NCT NCT03427749)
NCT ID: NCT03427749
Last Updated: 2025-04-10
Results Overview
MBF was measured locally and at a core laboratory using commercially available software. The acquisition protocol was standardized between the local site and core laboratory. a one-day rest-stress protocol was used. Relative perfusion images were obtained after tracer injection. All raw study data were transferred to the core laboratory where processing was independently repeated by one reader to evaluate inter site processing consistency. Perfusion scores were compared with the measured MBF.
COMPLETED
35 participants
The average total amount of time that the patient was assessed for the MBF protocol varied between 71 and 122 minutes.
2025-04-10
Participant Flow
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) and who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%).
Patients were excluded from the study prior to performing the research imaging if they had PCI or CABG after the consent process. Patients who were found to be pregnant or breastfeeding post consent were also excluded.
Participant milestones
| Measure |
SPECT Imaging With 99mTc-Tetrofosmin
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) and who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%). Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin
SPECT Imaging with 99mTc-Tetrofosmin Research Imaging: This is an observational study; patients will be managed according to the standard clinical care of the local site. Study end will be defined as completion of all SPECT imaging at rest and stress. Studies will be acquired at 6 initial sites with mixed prior experience at MBF imaging, to demonstrate feasibility of use in a clinical setting.
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Overall Study
STARTED
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35
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Overall Study
COMPLETED
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35
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SPECT Imaging With 99mTc-Tetrofosmin
n=35 Participants
Patients will be recruited from those referred to the local site's Diagnostic Imaging Department for SPECT myocardial perfusion imaging (MPI) and who have an intermediate to high pre-test likelihood of disease (Diamond-Forrester criteria ≥ 30%). Research imaging will consist of a SPECT acquisition at the time of rest and stress radiotracer injection in addition to the standard (delayed) clinical stress/rest SPECT scan with 99mTc-tetrofosmin
SPECT Imaging with 99mTc-Tetrofosmin Research Imaging: This is an observational study; patients will be managed according to the standard clinical care of the local site. Study end will be defined as completion of all SPECT imaging at rest and stress. Studies will be acquired at 6 initial sites with mixed prior experience at MBF imaging, to demonstrate feasibility of use in a clinical setting.
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Age, Continuous
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69 years
n=35 Participants
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Sex: Female, Male
Female
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6 Participants
n=35 Participants
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Sex: Female, Male
Male
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29 Participants
n=35 Participants
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Suspected or known coronary artery disease
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35 Participants
n=35 Participants
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PRIMARY outcome
Timeframe: The average total amount of time that the patient was assessed for the MBF protocol varied between 71 and 122 minutes.Population: Myocardial perfusion images were acquired from patients undergoing clinically indicated single photon emission computed tomography myocardial perfusion imaging. Patients were included if they were at least 18 years of age, had a body mass index of less than 40kg/m2, and were of intermediate to high pretest probability of coronary artery disease on a stable medication regimen. All 35 patients scanned were included in the study.
MBF was measured locally and at a core laboratory using commercially available software. The acquisition protocol was standardized between the local site and core laboratory. a one-day rest-stress protocol was used. Relative perfusion images were obtained after tracer injection. All raw study data were transferred to the core laboratory where processing was independently repeated by one reader to evaluate inter site processing consistency. Perfusion scores were compared with the measured MBF.
Outcome measures
| Measure |
SPECT Imaging With 99mTc-Tetrofosmin
n=35 Participants
Participants were injected with 42 +/-14 MBq of 99mTc-Tetrofosmin 20 minutes before imaging. dynamic tracer injections were delivered using a syringe pump over a duration of 30 seconds, followed by a 60 second flush. The injection flow rate was 14 mL/min for (7mL tracer, 14 mL flush). List mode data were acquired starting immediately before tracer injection and for a duration of 11 minutes. Relative perfusion images were obtained between 30 and 60 minutes after tracer injection for clinical evaluation. Each site acquired 35 patient data sets which were analyzed as part of the trial. All raw study data was transferred to the core laboratory where processing was independently repeated by one reader to evaluate inter-site processing consistency.
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Correlation in MBF Between Core Laboratory and Local Site
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0.93 correlation coefficient
Interval 0.87 to 0.97
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SECONDARY outcome
Timeframe: The average total time the patient was in the camera room during the study protocol was 72.28 minutes.Population: Myocardial perfusion images were acquired from patients undergoing clinically indicated single photon emission computed tomography myocardial perfusion imaging. Patients were included if they were at least 18 years of age, had a body mass index of less than 40kg/m2, and were of intermediate to high pretest probability of coronary artery disease on a stable medication regimen. All 35 patients scanned were included in the study.
Additional acquisition time for the MBF acquisition. For each patient study, the time during which the patient was in the camera room for each imaging session was recorded along with the start times for each scan. From this data, the increase in time for MBF protocol compared with the time for a standard myocardial perfusion imaging protocol was determined.
Outcome measures
| Measure |
SPECT Imaging With 99mTc-Tetrofosmin
n=35 Participants
Participants were injected with 42 +/-14 MBq of 99mTc-Tetrofosmin 20 minutes before imaging. dynamic tracer injections were delivered using a syringe pump over a duration of 30 seconds, followed by a 60 second flush. The injection flow rate was 14 mL/min for (7mL tracer, 14 mL flush). List mode data were acquired starting immediately before tracer injection and for a duration of 11 minutes. Relative perfusion images were obtained between 30 and 60 minutes after tracer injection for clinical evaluation. Each site acquired 35 patient data sets which were analyzed as part of the trial. All raw study data was transferred to the core laboratory where processing was independently repeated by one reader to evaluate inter-site processing consistency.
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Impact on Throughput
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72.28 minutes
Standard Deviation 9.6
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Adverse Events
SPECT Imaging With 99mTc-Tetrofosmin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Terrence Ruddy
University of Ottawa Heart Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place