Trial Outcomes & Findings for Cadmium-zinc-telluride (CZT) Imaging of Myocardial Blood Flow (MBF) (SPECT MBF) (NCT NCT02280941)
NCT ID: NCT02280941
Last Updated: 2025-04-06
Results Overview
PET studies were acquired with either 82Rb or 13N-ammonia according to clinical protocol. The activity injected at both rest and stress was 10 MBq/kg (82Rb) or 5MBq/kg (ammonia). MBF was based on data acquired over 8 min (82Rb) or 4 min (ammonia). SPECT rest images were obtained for 11 min starting immediately before injection of 316 +/- 71 MBq of 99mTc-tetrofosmin. The patient returned at 45 min after injection for a 5 min static resting acquisition (corresponding to the standard time for myocardial perfusion imaging). Without repositioning, the patient was stressed using dipyridamole (0.14mg/kg/min for 5 minutes) with 11 minutes of list mode data acquired starting immediately before the injection of 1122 +/- 170 MBq of tetrofosmin. Both rest and stress injections were delivered mechanically over 30 seconds. A standard set of stress perfusion images were acquired at 45 mins after tracer injection. The myocardial blood flow obtained using SPECT was compared to the patient's PET.
COMPLETED
NA
66 participants
From enrollment to completion of imaging was a maximum of four weeks. The average difference in acquisition dates was 19 +/- 9 days.
2025-04-06
Participant Flow
Recruited 32 patients with known coronary artery disease. Patients were recruited from diagnostic clinic lists.
Enrolled patients who underwent CABG or PCI after they provided consent were excluded from the study. Enrolled patients who experienced acute myocardial infarction or acute coronary syndrome any time after the consent, were also excluded. Enrolled patients with a positive pregnancy screen prior to their research scan were excluded from the study.
Participant milestones
| Measure |
Single Photon Emission Computed Tomography
Myocardial blood flow (MBF) measurement will be analyzed using attenuation and scatter corrected dynamic single photon emission computed tomography (SPECT) imaging data. The data will be compared to MBF obtained from positron emission tomography (PET) imaging.
single photon emission computed tomography: Single photon emission computed tomography (SPECT) imaging will be done.
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Overall Study
STARTED
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32
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Overall Study
COMPLETED
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31
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Overall Study
NOT COMPLETED
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1
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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 |
Single Photon Emission Computed Tomography
n=31 Participants
Myocardial blood flow (MBF) measurement will be analyzed using attenuation and scatter corrected dynamic single photon emission computed tomography (SPECT) imaging data. The data will be compared to MBF obtained from positron emission tomography (PET) imaging.
single photon emission computed tomography: Single photon emission computed tomography (SPECT) imaging will be done.
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Age, Continuous
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64 years
STANDARD_DEVIATION 11 • n=31 Participants
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Sex: Female, Male
Female
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4 Participants
n=31 Participants
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Sex: Female, Male
Male
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27 Participants
n=31 Participants
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Region of Enrollment
Canada
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31 participants
n=31 Participants
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Suspected or known coronary artery disease
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31 Participants
n=31 Participants
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PRIMARY outcome
Timeframe: From enrollment to completion of imaging was a maximum of four weeks. The average difference in acquisition dates was 19 +/- 9 days.Population: Patients with known coronary artery disease who underwent both PET and SPECT myocardial perfusion imaging within 4 weeks.
PET studies were acquired with either 82Rb or 13N-ammonia according to clinical protocol. The activity injected at both rest and stress was 10 MBq/kg (82Rb) or 5MBq/kg (ammonia). MBF was based on data acquired over 8 min (82Rb) or 4 min (ammonia). SPECT rest images were obtained for 11 min starting immediately before injection of 316 +/- 71 MBq of 99mTc-tetrofosmin. The patient returned at 45 min after injection for a 5 min static resting acquisition (corresponding to the standard time for myocardial perfusion imaging). Without repositioning, the patient was stressed using dipyridamole (0.14mg/kg/min for 5 minutes) with 11 minutes of list mode data acquired starting immediately before the injection of 1122 +/- 170 MBq of tetrofosmin. Both rest and stress injections were delivered mechanically over 30 seconds. A standard set of stress perfusion images were acquired at 45 mins after tracer injection. The myocardial blood flow obtained using SPECT was compared to the patient's PET.
Outcome measures
| Measure |
Comparision of Myocardial Blood Flow Between PET to SPECT Myocardial Perfusion Imaging.
n=31 Participants
Myocardial blood flow (MBF) measurement was analyzed using attenuation and scatter corrected dynamic single photon emission computed tomography (SPECT) imaging data. The data will be compared to MBF obtained from positron emission tomography (PET) imaging.
PET studies were acquired with either 82Rb or 13N-ammonia according to clinical protocol. The activity injected at both rest and stress was 10 MBq/kg (82Rb) or 5MBq/kg (ammonia). MBF was based on data acquired over 8 min (82Rb) or 4 min (ammonia). SPECT rest images were obtained for 11 min starting immediately before injection of 316 +/- 71 MBq of 99mTc-tetrofosmin. The patient returned at 45 min after injection for a 5 min static resting acquisition (corresponding to the standard time for myocardial perfusion imaging). Without repositioning, the patient was stressed using dipyridamole (0.14mg/kg/min for 5 minutes) with 11 minutes of list mode data acquired starting immediately before the injection of 1122 +/- 170 MBq of tetrofosmin. Both rest and stress injections were delivered mechanically over 30 seconds. A standard set of stress perfusion images were acquired at 45 mins after tracer injection
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Difference Between Measurements of Myocardial Blood Flow Measured With PET and With SPECT
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0.06 mean residual difference in MBF
Standard Deviation 0.37
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PRIMARY outcome
Timeframe: From enrollment to completion of imaging was a maximum of four weeks.Population: Patients scheduled for clinically indicated SPECT myocardial perfusion studies who had an intermediate to high pretest probability of disease were 18 years of age or older and had a BMI \< 40kg/m2 were recruited to the study.
SPECT myocardial blood flow (MBF) was measured and repeated at a mean interval of 18 days to assess precision of MBF measurements between the two scans.
Outcome measures
| Measure |
Comparision of Myocardial Blood Flow Between PET to SPECT Myocardial Perfusion Imaging.
n=30 Participants
Myocardial blood flow (MBF) measurement was analyzed using attenuation and scatter corrected dynamic single photon emission computed tomography (SPECT) imaging data. The data will be compared to MBF obtained from positron emission tomography (PET) imaging.
PET studies were acquired with either 82Rb or 13N-ammonia according to clinical protocol. The activity injected at both rest and stress was 10 MBq/kg (82Rb) or 5MBq/kg (ammonia). MBF was based on data acquired over 8 min (82Rb) or 4 min (ammonia). SPECT rest images were obtained for 11 min starting immediately before injection of 316 +/- 71 MBq of 99mTc-tetrofosmin. The patient returned at 45 min after injection for a 5 min static resting acquisition (corresponding to the standard time for myocardial perfusion imaging). Without repositioning, the patient was stressed using dipyridamole (0.14mg/kg/min for 5 minutes) with 11 minutes of list mode data acquired starting immediately before the injection of 1122 +/- 170 MBq of tetrofosmin. Both rest and stress injections were delivered mechanically over 30 seconds. A standard set of stress perfusion images were acquired at 45 mins after tracer injection
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Precision of Myocardial Blood Flow Measurements Between Two SPECT Scans
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29.5 % difference in MBF between SPECT scans
Standard Deviation 1.5
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Adverse Events
Difference Between Measurements of Myocardial Blood Flow Measured With PET and With SPECT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place