FREQUENTLY ASKED QUESTIONS

The criteria listed are guidelines only.
The frequency should be specified at time of enrollment; we won’t necessarily report this, but documenting is useful as it will help coordinators follow for protocol deviations. Also, it will help us deal with monitoring the issue of whether the patient received a transplant too fast--that is, before they should have been screened according to standard of care.
We all recognize this as a major issue so we do not want a diabetic who should have been screened at 12 months but was not tested and then got transplant at 16 months to be retrospectively assigned a screening frequency of 24 months. The protocol is clear that the screening frequency must be specified at enrollment and prior to randomization.

The patient should have their screening test once reactivated (ideally soon after reactivation).

Yes.

Example: Mr X is randomised to NO SCREENING. He had an annual TTE that was done as he complained of shortness of breath. The TTE showed severe pulmonary hypertension, and he had a right heart catheterization done on 26/11/2018. Spirometry- NAD. VQ-upper diversion of perfusion may be suggestive of heart failure. He is scheduled to have treadmill stress test on the 17/12/2018. In this case, no it is not a PV, because the patient reported symptoms that could be interpreted as having CAD.

Please record this test in CRF 8 as “unplanned” and tick “yes’ for “was the test performed for symptoms suggestive of CAD?”. A protocol deviation is defined as a screening test that was performed when it was NOT clinically indicated.

As the patient’s last screening test was 1.5 years ago, he would be due for a test in 6 month's time. If he is randomised to REGULAR screening, his next test should be done within 6 months. If he randomised to NO FURTHER SCREENING, he does not require another screening test.

No. There is no need to fill out CRF 5 (hospitalisations) in addition to the MI/angiogram/death forms as these events occurred during the same hospitalisations.

This patient should be followed for 12 months posttransplant for cardiac events and remain in the original assignment arm.

How do I know which patients can "roll over" to the CARSK trial?

The steering committee agrees that we are studying the intention to screen; therefore, some patients may be transplanted fewer than 12 months from the date of enrollment and still be informative to the trial.

The easiest way to distinguish eligible and noneligible patients for roll over is the following approach:

• If the patient had a transplant more than 12 months from date of enrollment = definitely eligible.
• If the transplant was fewer than 12 months from day of enrollment, determine if they have DM:
• If DM: Look at date of last pre-enrollment noninvasive screening test. If the difference between the date of that test and transplant is greater than 12 months, the patient is eligible.
• If NOT DM: Look at date of last pre-enrollment noninvasive screening test. If the difference between the date of that test and transplant is 24 months, the patient is eligible.

The only gap in the above would be people who were delisted or died. We will discuss these hopefully small number of patients with you to determine if they are potentially still informative for the study. They might be more difficult to include so please bring these to the study manager for consultation by the steering committee.

If a patient is having a MIBI every 2 years, and has last had one in summertime 2018, what are the date ranges allowable before the timing is considered a deviation?

We don’t mandate a timeframe, but within 3 months is usually aceptable.
The only deviation to report is if a test was done for no reason in a no-screening patient.

Actively wait-listed 55-year-old diabetic (mature-onset) scenario:

• Blood group A, 0% cPRA
• On list for 1.3 years; expected to receive an offer within next 10 months
• Asymptomatic
• Last MIBI was 24 months ago

Even though the patient will undergo transplant within next 10-12 months, he is past due for a MIBI test by SoC

If you are happy for him to remain on your WL from a clinical perspective, he can be enrolled and randomized (i.e. you have to be happy with him potentially being randomized to no-screening...)

Caveat if he is randomized to regular screening, the MIBI must be ordered right away and completed before the anticipated date of transplantation.

In summary, this patient IS ELIGIBLE.

Actively waitlisted 50 year old male scenario:

• Blood group 0, 40% cPRA
• CABG 33 months ago
• On list for 2.5 years; expected to receive an offer in next 12-15 months
• Asymptomatic, swimming 30 min 3x/ week
• Last MIBI: none since CABG; had echo 1 year post-CABG that showed preserved LV function

Even though the patient will undergo transplant within next 12 months, he will be due for a MIBI test by SoC in 3 months (i.e. 36 months post-CABG).

If you are happy for him to remain on your WL from a clinical perspective, he can be enrolled and randomized.

Caveat if he is randomized to regular screening the MIBI must be ordered to take place in 3 months so that it is done well before the anticipated date of transplantation.

In summary, this patient IS ELIGIBLE.

Asymptomatic, active 48-year-male PKD, not yet wait-listed scenario:

• Blood group A, 0% cPRA
• likely to be transplanted in next 4-6 mo
• started dialysis 18 months ago
• Last MIBI: 28 months ago, normal

If you are happy for him to be randomized without further testing, he could possibly be enrolled…

If randomized to regular screening, he would need a MIBI right away.

But: He lives in a remote community and it may be difficult to get MIBI in next 4 months.

In summary, this patient is NOT ELIGIBLE.