Data

Canadian Australasian Randomised trial of Screening Kidney transplant recipients for coronary artery disease (CARSK) dataset

The University of Sydney

Dataset description

This dataset will include up to 3,306 adult kidney transplant candidates. Baseline data will include demographics and health related quality of life. Follow-up data will be collected at 6 and 12 months and then 6 monthly thereafter for the duration of the study (5 years) will include health related quality of life and clinical outcomes (major adverse cardiac event).
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Subjects

Renal medicine |

Related Study

Canadian-Australian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease

Brief Summary

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.

Inclusion Criteria

  • 1. adults aged 18 years of age or older 2. Dialysis-dependent kidney failure and currently being assessed for OR active on the kidney transplant waiting list 3. expected to require further screening for CAD prior to transplantation (by current standard of care); 4. able to give consent; 5. anticipated to undergo transplantation more than 12 months from date of enrolment

Study Type

  • Interventional

Ethics Approval

Study Protocol: Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

Researchers requesting individual patient data will be considered on a case by case basis by the trial steering committee

When will data be available?

Data will only be available after trial conclusion (approximately 2024-2025) for a period of 15 years.

Available to whom?

available to all researchers on a case by case basis

Available for what types of analyses?

data analyses will be considered on a case by case basis