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Am J Kidney Dis. 2011 Jun;57(6):908-16. doi: 10.1053/j.ajkd.2011.01.020. Epub 2011 Mar 15.

Design considerations and feasibility for a clinical trial to examine coronary screening before kidney transplantation (COST).

Author information

1
Department of Medicine, Hennepin County Medical Center, 701 Park Avenue, Minneapolis, MN 55415, USA. kasis001@umn.edu

Abstract

BACKGROUND:

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

STUDY DESIGN:

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

SETTING & PARTICIPANTS:

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

PREDICTORS:

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

OUTCOMES:

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

MEASUREMENTS:

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.

RESULTS:

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.

LIMITATIONS:

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

CONCLUSION:

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

PMID:
21411203
PMCID:
PMC3587732
DOI:
10.1053/j.ajkd.2011.01.020
[Indexed for MEDLINE]
Free PMC Article
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