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ACRIN PA 4005 CRF COMPLETION INSTRUCTIONS
DP Completion Instructions
The DP Form is used to collect clinical data for various heart imaging procedures in either Group A or B
participants. The DP form should be completed by the study site RA’s for all participants. Please answer
each main heading ‘No/Yes’ question in the DP form. If the answer is “Yes” to any main heading question,
(i.e. Stress Test), please complete all the sub-questions under that heading. All Date(s) in the “a” subquestions pertain to the date the particular test was performed.
Please be sure to follow your IRB and institution policies. All available dates should be reported as MM-DDYYYY. Code all questions unless otherwise specified. Do not leave mandatory questions blank.
Note: These completion instructions only include questions that may need further clarification. Below is a
list of such questions and how they should be documented for this study.
Question 1: Stress Test
1b. Type of stress test
Select type of medication used for medicinally induced stress tests. If an exercise (treadmill) stress test was
done, select accordingly.
1e. Was stress imaging performed?
Please answer the ‘No/Yes’ response. Stress imaging is usually performed with medicinally induced stress
testing. There may be reasons imaging is not performed, including exercise stress testing. If stress
imaging was performed, please specify which method of imaging was used (nuclear, echo, MR). It is then
required to complete the entire section of imaging method used.
Example:
a) Participant had a dobutamine stress test performed and was scanned in nuclear imaging.
You would mark ‘Nuclear” in Q 1e, complete 1f, then complete the entire section of Nuclear Imaging
(Question 2).
b) Participant had a dobutamine stress test performed and was scanned in MR (magnetic resonance)
You would mark ‘MR” in Q 1e, complete 1f, then complete the entire section of MR Imaging
(Question 4)
1f. Was test positive for reversible disease?
This is a very important study endpoint question. This sub-question must be answered if a (stress) test
was done. If (stress) imaging was not performed, mark ‘unknown’. This question is repeated in each
method of imaging (main heading).
Question 2: Nuclear Imaging
2b. Modality
It is possible a “resting” (non-stress) nuclear scan can be done of the heart. In this study most will likely be
done within stress modality.
2c. Perfusion
Complete one response only. If response is any defect (reversible, fixed, mixed), please complete in the text
field below, the location of the heart where defect occurred. Also mark defect severity (mild, moderate or
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ACRIN PA 4005 CRF COMPLETION INSTRUCTIONS
severe) if there is a defect recorded. If perfusion is marked ‘normal’, then the defect location text and severity
is not necessary to complete.
2d. Did Transient Cavity Dilation occur?
This question pertains to compensatory enlargement of the cavities (i.e. ventricles) of the heart, with thinning
of its walls that may have been reported.
2e. Wall Motion (Global)
Select one global impairment or ‘none’.
2f. Regional Wall Motion Abnormality
Check all that apply. If regional wall motion not recorded, mark ‘not performed’.
Question 3: Echocardiogram
3c. Resting Left Ventricular Systolic Function
Complete if echocardiogram was done as a resting test. If stress echo was done, mark ‘N/A’.
3d. Stress Left Ventricular Systolic Function
Complete if echocardiogram was done as a stress test. If a resting echo was done, mark ‘N/A’.
3e. Ejection Fraction
This is the fractional volume of blood (percentage) that leaves the left ventricle during contraction. This
requires a 2 digit whole number. If not known or not done, please mark “unknown”.
3f. Regional Wall Motion Abnormality (refer to 2f instruction.)
Question 4: MR Imaging (refer to Q 3 sub-question instructions)
4h. Was there delayed enhancement?
MR may have delayed enhancement of images. Please mark No/Yes or not performed as appropriate. If yes,
please complete 4i.
4i. Delayed enhancement description
Mark in text field location and/or extent of enhancement. If finding is unknown, text ‘unknown’ in the field.
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Question 5: Cardiac Catheterization
5c. Percentage of Maximal Stenosis
This requires a 2 digit whole number. It is required that all four segment fields be completed. If there is a
clean artery with no stenosis, mark 0 in field.
Question 6: Revascularization
If marked yes, please complete type of revascularization was done to participant. It is possible that the patient
had a failed PTCA and CABG done shortly following.
6a. Date of Revascularization
It is required to record the date(s) when the revascularization procedure(s) occurred.
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