Design considerations and feasibility for a clinical trial to examine coronary screening before kidney...

It is unclear whether benefits outweigh harms for routine screening and prophylactic revascularization to prevent coronary artery disease (CAD) in asymptomatic kidney transplant candidates.

Pilot feasibility study with prospective observational data collection and patient interviews.

Consecutive patients referred for kidney and/or pancreas transplant at 26 major transplant centers in the United States.

Older age, diabetes, prior cardiovascular disease, and multiple traditional CAD risk factors.

Eligibility and willingness to participate in a randomized controlled trial (RCT) to study the effect of CAD screening on major adverse cardiac events.

Patients who would be candidates for a hypothetical RCT of CAD screening were interviewed and asked if they would participate in such a trial. Sample size for the trial was estimated using data for Medicare patients in the US Renal Data System with major adverse cardiac events as the primary end point.

Of consecutive eligible patients, CAD evaluation was not indicated in 398 (24%), already completed before referral in 602 (36%), and pending (and hence eligible for an RCT) in 665 (40%). Of 241 interviewed, 73% indicated they would be willing to participate in an RCT. We estimated that ~4,000 would need to be enrolled to detect a 20% decrease in major adverse cardiac events at >80% power at P < 0.05.

Willingness to participate in an actual clinical trial may be different from indicated in an interview.

An RCT to compare the effects of routine screening for CAD versus no screening on major adverse cardiac events is feasible.