Trial Outcomes & Findings for Rapid Stress/Rest Single-Day Tc-99m Sestamibi Myocardial Single Photon Emission Computed Tomography (NCT NCT01434641)
NCT ID: NCT01434641
Last Updated: 2016-04-11
Results Overview
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.
COMPLETED
NA
102 participants
at 12 minutes
2016-04-11
Participant Flow
102 consecutive patients referred for clinically indicated myocardial perfusion SPECT were recruited.
Participant milestones
| Measure |
Stress/Rest Myocardial Perfusion SPECT Patients
All patients referred for clinically indicated myocardial perfusion SPECT are eligible candidates for this protocol. Low-dose stress/high-dose rest myocardial perfusion SPECT is performed according to the protocol and image quality and rest/stress myocardial count density ratios are assessed.
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|---|---|
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Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rapid Stress/Rest Single-Day Tc-99m Sestamibi Myocardial Single Photon Emission Computed Tomography
Baseline characteristics by cohort
| Measure |
Myocardial Perfusion SPECT
n=102 Participants
The 102 study patients underwent a very low-activity stress/high-activity rest, single-day myocardial perfusion SPECT ith a conventional sodium iodide camera and wide beam reconstruction processing.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=5 Participants
|
|
Weight
|
178 pounds
STANDARD_DEVIATION 41 • n=5 Participants
|
|
Chest circumference
|
41.5 inches
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Coronary Artery Disease
yes
|
53 participants
n=5 Participants
|
|
Coronary Artery Disease
no
|
49 participants
n=5 Participants
|
|
Risk of Coronary Artery Disease
yes
|
37 participants
n=5 Participants
|
|
Risk of Coronary Artery Disease
no
|
65 participants
n=5 Participants
|
|
Non-cardiac surgery
yes
|
12 participants
n=5 Participants
|
|
Non-cardiac surgery
no
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 12 minutesSPECT 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.
Outcome measures
| Measure |
Myocardial Perfusion SPECT
n=102 Participants
Participants underwent novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
|
|---|---|
|
Myocardial Perfusion SPECT Image Quality 12 Minutes
Stress non-gated Poor
|
1 participants
|
|
Myocardial Perfusion SPECT Image Quality 12 Minutes
Stress gated Poor
|
0 participants
|
|
Myocardial Perfusion SPECT Image Quality 12 Minutes
Stress non-gated Fair
|
8 participants
|
|
Myocardial Perfusion SPECT Image Quality 12 Minutes
Stress gated Fair
|
3 participants
|
|
Myocardial Perfusion SPECT Image Quality 12 Minutes
Stress non-gated Good
|
30 participants
|
|
Myocardial Perfusion SPECT Image Quality 12 Minutes
Stress gated Good
|
20 participants
|
|
Myocardial Perfusion SPECT Image Quality 12 Minutes
Stress non-gated Excellent
|
63 participants
|
|
Myocardial Perfusion SPECT Image Quality 12 Minutes
Stress gated
|
79 participants
|
PRIMARY outcome
Timeframe: at 16 minutesPopulation: Of the total 102 patients enrolled, additional 16-minute post-stress SPECT was performed on 37 patients.
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.
Outcome measures
| Measure |
Myocardial Perfusion SPECT
n=37 Participants
Participants underwent novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
|
|---|---|
|
Myocardial Perfusion SPECT Image Quality 16 Minutes
Stress non-gated Poor
|
0 participants
|
|
Myocardial Perfusion SPECT Image Quality 16 Minutes
Stress gated Poor
|
0 participants
|
|
Myocardial Perfusion SPECT Image Quality 16 Minutes
Stress non-gated Fair
|
1 participants
|
|
Myocardial Perfusion SPECT Image Quality 16 Minutes
Stress gated Fair
|
1 participants
|
|
Myocardial Perfusion SPECT Image Quality 16 Minutes
Stress non-gated Good
|
7 participants
|
|
Myocardial Perfusion SPECT Image Quality 16 Minutes
Stress gated Good
|
7 participants
|
|
Myocardial Perfusion SPECT Image Quality 16 Minutes
Stress non-gated Excellent
|
29 participants
|
|
Myocardial Perfusion SPECT Image Quality 16 Minutes
Stress gated Excellent
|
30 participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
Myocardial Perfusion 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