Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    3306
  • sponsor
    University of British Columbia
Updated on 6 May 2021
arteriopathy
metastases
kidney transplant
renal failure
dialysis
coronary disease
kidney failure

Summary

The Canadian Australasian Randomized Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease (CARSK) will test the hypothesis that eliminating the regular use of non-invasive screening tests for CAD AFTER waitlist activation is not inferior to regular (i.e., annual) screening for CAD during wait-listing for the prevention of Major Adverse Cardiac Events. Secondary analyses will assess the impact of screening on the rate of transplantation, and the relative cost-effectiveness of screening.

Description

Cardiovascular disease is the commonest cause of death while on the kidney transplant waiting list and after transplantation. Current standard care involves screening for coronary artery disease prior to waitlist entry, then every 1-2 years, according to perceived risk, until transplanted. The aim of screening is two-fold. Firstly to identify patients with asymptomatic coronary disease to enable either correction, by bypass surgery or angioplasty, or removal of the patient from the list, with the ultimate aim of preventing premature cardiovascular mortality at the time of, or soon after kidney transplantation. Secondly, from a societal perspective, to prevent mis-direction of scarce donor organs into recipients who experience early mortality. This current screening strategy is not evidence based, has substantial known and potential harms, and is very costly. Two major issues of uncertainty require addressing in sequence: (1) whether to periodically screen asymptomatic wait-listed patients for occult coronary artery disease; and (2) whether to revascularise coronary stenoses in asymptomatic patients prior to transplantation. The CARSK study seeks to address the first of these 2 issues.

CARSK aims to

  1. Test the hypothesis that after screening for wait list entry, no further screening for coronary artery disease (CAD) is non-inferior to the current standard care which is screening all asymptomatic wait-listed patients for CAD at regular intervals.
  2. Compare the benefits and costs of not screening versus regular CAD screening from a health system perspective.

Details
Condition Chronic renal failure, Organ Transplantation, Cardiovascular Disease, Renal transplant, Stage 5 Chronic Kidney Disease, Organ Transplant - Pediatric, Chronic Kidney Disease Stage 5, Dialysis Related Complication, CKD Stage 5, Organ Transplant, Kidney Transplantation, kidney transplant, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders, renal transplantation, kidney transplants, end stage renal disease, chronic renal disease, end-stage renal disease, esrd, end-stage renal failure, end stage kidney disease, end stage renal failure
Treatment No screening, Regular Screening
Clinical Study IdentifierNCT03674307
SponsorUniversity of British Columbia
Last Modified on6 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic renal failure or Kidney Transplantation or Organ Transplant or Renal transplant or Organ Transplantation or Cardiovascular Disease or Organ Tr...?
Do you have any of these conditions: cardiovascular disorders or end stage kidney disease or Stage 5 Chronic Kidney Disease or end stage renal disease or esrd or Chronic Kidney Disease St...?
Do you have any of these conditions: end-stage renal disease or CKD Stage 5 or Chronic Kidney Disease Stage 5 or Renal transplant or renal transplantation or cardiovascular disorders or e...?
Do you have any of these conditions: Cardiovascular Disease or Chronic renal failure or Organ Transplant or cardiovascular diseases or end-stage renal disease or cardiovascular disease (c...?
adults aged 18 years of age or older
Dialysis-dependent kidney failure and currently being assessed for OR active on the kidney transplant waiting list
expected to require further screening for CAD prior to transplantation (by current standard of care)
able to give consent
anticipated to undergo transplantation more than 12 months from date of enrolment

Exclusion Criteria

patients with signs or symptoms suggestive of uncontrolled cardiac disease such as unstable coronary syndromes, decompensated heart failure, uncontrolled arrhythmia, and severe valvular heart disease
patients who "on-hold" for transplantation due to a medical problem
patients with other solid organ transplants
multi-organ transplant candidates (e.g. kidney-pancreas transplant candidates)
patients with planned living donor transplant
patients unable to give consent
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