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ACRIN 4701 RESCUE SP CRF COMPLETION INSTRUCTIONS
SPECT MPI Diagnostic Imaging Form
The purpose of the SP form is to collect the clinical, diagnostic and radiological data that occur with SPECT myocardial
perfusion imaging (Group A).
There are 4 scenarios when the SPECT study is positive for ischemia for the purposes of the trial:
1.
2.
3.
4.
Positive EKG changes for ischemia and positive for Transient Ischemic Dilation (TID)
Reversible defect size of the entire myocardium > or = 10% by quantitative analysis method
Summed Difference Score (SDS) is > or = 7 in a 17 segment model by semi quantitative analysis method
Summed Difference Score (SDS) is > or = 8 in a 20 segment model by semi quantitative analysis method
The SPECT MPI software program determines the analysis method. For example, most versions of Emory Cardiac
Toolbox and Corridor 4DM SPECT report reversible defect size while most versions of Cedars Sinai QPS report the
summed difference score. When capable of reporting reversible defect size and the summed difference score report
the reversible defect size. Do not report findings for both methods. Do report findings using the same method for all
patients.
For diagnostic stress-only studies, report only the summed stress score (SSS) for all software programs i.e. Emory
Cardiac Toolbox, Corridor 4DM SPECT, Cedars-Sinai QPS, Wackers-Liu CQ, etc.
General: Dates are recorded as MM/DD/YYYY. Answer all questions unless otherwise specified. Full names of
personnel are only required for site source documentation (external use only) and are not required by ACRIN.
Reader ID: The reader ID consists of two letters followed by five digits.
1) Date of stress MPI - Enter the date the imaging occurred. For a 2-Day Protocol record the date of the first set of
images.
a. Date of interpretation- Enter the date the radiologist read the images.
b. Is this a repeat of a previous uninterpretable 4701 RESCUE protocol SPECT scan? Select “Yes” or “No” as
applicable.
2) Was this SPECT'S perfusion interpretable at all? - Was the perfusion able to be read and diagnosed? If “No”
provide the reason it was not interpretable in Q2a. If the scan is not interpretable for the purposes of the trial,
then do not complete Q14 to Q20.
a. Reason not interpretable – Select the most appropriate reason why the scan was not able to be
interpreted. If “Other” specify the reason.
3) Was exercise test performed? - If treadmill or bicycle exercise was performed select “Yes” if not select “No” and
skip to Q8.
4) What type of exercise stress was performed? - Check at least one, but check all exercise protocols that were
used for this procedure whether tolerated or not by participant.
5) Total time participant exercised: - Record minutes and seconds using 2 whole numbers. Enter each number in
the separate fields. Example- total time exercised was 10.30. Enter 10 minutes then enter 30 seconds.
6) METS (metabolic equivalent): - Enter a whole number within 1-20 range or select “Unknown”.
a. % of MPHR (maximum % heart rate) – Enter a whole number within 20-100 range or select “Unknown”.
4701 SP Completion Instructions for V3.0
May 12, 2017
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ACRIN 4701 RESCUE SP CRF COMPLETION INSTRUCTIONS
SPECT MPI Diagnostic Imaging Form
7) Was exercise test completed? - If treadmill or bicycle exercise was started but not finished or if the exercise test
was converted to a pharmacologic stress test enter “No” and answer Q7a. If the treadmill or bicycle exercise was
completed, enter “Yes”.
8) What type of pharmacologic stress was performed? – Select agent used, and enter the dosage. If “Other”
specify the pharmacologic. Use of a decimal number is required for dosage. If the dosage is not recorded in the
report, select ‘Unknown dosage’.
a. Pharmacologic Stress adjuncts used. - Select additional medications used during the pharmacologic
stress test. Use of a decimal number is required for dosage. If the dosage is not recorded in the report,
select ‘Unknown dosage’.
9) Are there EKG changes that meet the criteria for ischemia? - Ischemia is seen with ST depression or ST
elevation. Answer question 9 and answer questions 9a, 9b, 9c if the exercise test is positive for ischemia. .
Yes, to this question and yes to Q18 TID is present is a Yes response to Q19 that the SPECT study is positive for
ischemia.
10) Were any ventricular arrhythmias seen? – Select Yes or No as applicable.
11) Other heart abnormalities seen? – Select “Yes” or “No” as applicable. If “Yes” specify the abnormalities.
12) Did the patient develop symptoms of possible CAD during exam? - Select “Yes” or “No” as applicable. If “Yes,
then complete Q 12a and 12b.
a. If stress exercise did symptoms limit exercising capacity? – Select “Yes” if symptoms limited or stopped
the exercise portion of the SPECT.
b. If there were symptoms of possible CAD, list any symptoms experienced by the patient - What type of
symptoms were seen. Select all that apply. If “Other” specify the symptoms.
13) Cardiac monitoring - Complete all sections.
a. Baseline heart rate- Enter the resting heart rate up to a 3 digit number or select “Unknown”.
b. Peak Heart Rate- Enter the highest heart rate at stress up to a 3 digit number or select “Unknown”.
c. Systolic Blood Pressure at rest - Enter the resting systolic blood pressure up to a 3 digit number or select
“Unknown”.
d. Diastolic Blood Pressure at rest - Enter the resting diastolic blood pressure up to a 3 digit number or
select “Unknown”.
e. Systolic Blood Pressure at peak stress - Enter the highest systolic blood pressure achieved at stress up to
a 3 digit number or select “Unknown”.
f. Diastolic Blood Pressure at peak stress - Enter the highest diastolic blood pressure achieved at stress up
to a 3 digit number or select “Unknown”.
Important note: If 1st scan was not interpretable (Q2=no), then completion of questions 14 to 20 is not required.
Another TS and SP form will be triggered onto the case calendar. Input all scanning information up to this point to
monitor safety parameters of all trial procedures.
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ACRIN 4701 RESCUE SP CRF COMPLETION INSTRUCTIONS
SPECT MPI Diagnostic Imaging Form
14) Incidental findings – Select ‘Yes” or “No” for present for each category. If “Other” specify the location. If there
were incidental findings, enter “Yes” or “No” for requires follow-up. Incidental findings should be noted in the
patient’s nuclear cardiology report.
a. Was attenuation correction CT performed? - Select “Yes” or “No”. If “Yes”, complete Incidental findings,
select ‘Yes” or “No” for present for each category. If “Other” specify the location. If there were incidental
findings, enter “Yes” or “No” for requires follow-up. Incidental Findings should be noted in the patient’s
nuclear cardiology report.
15) Myocardial Perfusion
a. What was the perfusion in the septal/anterior/apical territory? – Select one.
b. What was the perfusion in the lateral myocardial territory? – Select one.
c. What was the perfusion in the inferior/ posterior myocardial territory? – Select one.
16) Quantitative perfusion scoring – Answer both 16a and 16b using quantitative analysis OR answer 16c using semi
quantitative analysis. If your software program has the capabilities to report 16a, 16b and 16c, report Q16a,
Q16b but not Q16c. Use the same type of analysis for all patients.
a. LV reversible defect size – Enter whole numbers in the range 0-100. An LV reversible defect > 10%,
indicates a positive scan and response to Q19 should be “Yes”. (If quantitative analysis was used and if
the reversible defect size cannot be assessed/artifact, then Q2 should be answered No and Q14-20 are
skipped.)
b. LV fixed defect size - Enter whole numbers in the range 0-100. (If quantitative analysis was used and if
the fixed defect size cannot be assessed/artifact, then Q2 should be answered No and Q14-20 are
skipped.)
c. Automated summed segment scores: - Provide three scores when using semi quantitative analysis
unless Stress-only SPECT imaging occurred. For Stress-only SPECT imaging provide the SSS and record
Unk/Not performed for SRS and SDS. Select 17 segment model or 20 segment model.
· SSS - Enter whole numbers in the range 0-80. (If semi quantitative analysis was used and if
summed scores cannot be assessed/artifact, then Q2 should be answered No and Q14-20 are
skipped.)
· SRS - Enter whole numbers in the range 0-80. “Unk/Not performed” is applicable for Stress-only
SPECT imaging. (If semi quantitative analysis was used and if summed scores cannot be
assessed/artifact, then Q2 should be answered No and Q14-20 are skipped.)
· SDS - Enter whole numbers in the range 0-80. A summed difference score (SDS) > or = 7 in a 17
segment model or a summed difference score (SDS) > or = 8 in a 20 segment model indicates a
positive scan and response to Q19 should be “Yes”. “Unk/Not performed” is applicable for
Stress-only SPECT imaging. (If semi quantitative analysis was used and if summed scores cannot
be assessed/artifact, then Q2 should be answered No and Q14-20 are skipped.)
17) Quantitative function – Left Ventricular Function. Report LVEF (Left Ventricular Ejection Fraction) as a whole
number.
a. Resting EF - Record Resting LV function as a whole number, if reported.
b. Post stress EF –Record Stress LV function as a whole number, if reported.
18) Was Transient Ischemic dilation (TID) observed? - Select “Yes” or “No” as applicable. Evaluation of TID is done
visually or by calculating the ratio between stress and rest images (reported by software).
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ACRIN 4701 RESCUE SP CRF COMPLETION INSTRUCTIONS
SPECT MPI Diagnostic Imaging Form
a. If a TID ratio is reported record it as a decimal number in the range of 0.5 to 2.0. If a TID is not reported
check unknown. If it is not clear, if TID is present on the SPECT report check with the SPECT reader.
‘Yes’ to this question and ‘yes’ to Q9 ECG changes met the criteria for ischemia is a Yes response to Q19.
19) Per 4701 RESCUE protocol is this a positive scan? - A Positive scan is defined as ‘yes’ to both Q9 and Q18 or Q16a
response is >= 10% or Q16c response SDS in a 17 segment model is >= 7 or Q16c response SDS in a 20 segment
model >= 8.
20) Per 4701 RESCUE protocol - which treatment is recommended based on results? - If positive results were found
as described above, the treatment should be ‘Diagnostic ICA.’ The response of ‘None’ is indicated for negative
scans, and participant should be followed with OMT as per protocol and physician decision. Review the case
record carefully for the medical treatment option decision the participant was elected to follow.
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