ACRIN 4701 RESCUE TCCRF COMPLETION INSTRUCTIONS

CCTA Technical Assessment Form

About 4701CCTA Technical Assessment (TC)

TheTC form is completed by the study dedicated Research Staff for participants who undergo contrast-enhanced CCTA following randomization to Group A for evaluation of suspected CAD. This form’s main purpose in this study is to record whether or not the scan was completed, scanner details, contrast and medications given.

This form is to be completed within two (2) weeks of consent.

A CCTA is done in 2 phases- the non- contrast ‘run’ and the contrast ‘run’. The non-contrast run is done first before the injection of contrast. This captures the heart calcium score. Often if calcium scores are too high, the CCTA will not be completed with the contrast run. The non-contrast run will also detect incidental findings in other anatomical areas (such as the lung).

General

Dates are recorded as MM/DD/YYYY. Time endpoints are captured in military time (24 hour clock) unless otherwise specified. Code all questions unless otherwise specified. Do not leave mandatory questions blank. Full names of personnel are only required for site source documentation (external use only) and are not required by ACRIN.

At the bottom of every form, there will be‘initial of person(s) completing the form’. The person completing the form represents the initials of the person responsible for reviewing the data and completing form (either web or paper).

If the RA/coordinator is acquiring the data from chart review or by administering participant questionnaire, he/she is the ‘person’ completing the form. If a physician completed a paper data form and the RA/coordinator transcribed the data completed by the physician onto the web form, the ‘initial of person(s) completing the form’ should be that of the physician, not the RA/coordinator.

Note: These completion instructions only include questions that may need further clarification.

Question 1:

If the procedure was not done, please enter the scheduled date of procedure. In the case whereby a procedure was not scheduled, enter the date participant was registered onto the study as date of procedure.Please document the date recorded in question 1 in the “Comment” section at the bottom of the form(ex: “registration date recorded in Q1 as procedure was not scheduled.”)

Question 2 and 2a

In Rescue, the non-contrast run is ‘optional’ per the protocol; however, each institution may do this as their standard of care.

Question 8:

If the reply to ‘Were any Adverse Events experienced during these scans?’is yes, complete the AE form (the AE form will be automatically set on the case calendar for completion)

Question 8a:

If the reply to “Was the AE a death?”is yes, then this case will be considered an adjudication case. You will be contacted by data management for medical records pertaining to the death so the adjudication process can begin.

Question 8b:

If the reply to “Was the AE an AMI?”is yes, then this case will be considered an adjudication case.Again, you will be contacted by data management for medical records pertaining to the AMI so the adjudication process can begin.

Question 9:

This question reply refers to open field techniques used in CT. If used, incidental findingsare sometimes identified more readily.

4701 TC Completion Instructions for V 3.008-27-2012page 1 of 2