Canadian Australasian Randomised trial of Screening Kidney transplant recipients for coronary artery disease (CARSK) dataset
The University of SydneyDataset 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).Subjects
Renal medicine |Identifiers
Source Study
Trial name (public)
Canadian-Australian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery DiseaseTrial acronym
CARSK study
Trial ID
ACTRN12616000736448
Purpose
Diagnosis
Phase
Not Applicable
Funding
Government body,National Health and Medical Research Council
Scientific enquiries
Dr Tracey Ying
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 th .... Read more
Key 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
Key Exclusion Criteria
1. 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; 2. patients who “on-hold” for transplantation due to a medical problem; 3. patients with other solid organ transplants; 4. multi-organ transplant candidates (e.g. kidney-pancreas transplant candidates); 5) patients with planned living donor transplant; 6) patients unable to give consent.
Can healthy volunteers participate?
No
Population
Sample Size 3306
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Coronary artery disease , Kidney failure , Kidney transplant
Condition code Cardiovascular , Renal and Urogenital
Intervention
Intervention code Early detection / Screening
Patients randomised to no screening will not undergo regular non-invasive testing for CAD while on the kidney transplant waitlist. The current practice for waitlisted patients is to be screened every 1-2 years based on perceived risk of CAD. At any time, if patients develop symptoms of CAD, they will be treated according to local standard of care. Patients in this group will be contacted every 6 months on the wait-list, and at 3 and 12 months post-transplant. The duration of the study will be 5 .... Read more
Comparison
Control group Active
Patients randomised to routine screening will undergo noninvasive testing for coronary artery disease every year or second yearly as determined by local transplant centre practice. The duration of screening in the control is same as the intervention group (5 years). Patients transplanted during the study will be followed for 12 months post-date of transplant and will exit study. This applies for both SCREENING and NO SCREENING groups.
Outcomes
Outcome: Primary efficacy: major adverse cardiac event (MACE), defined as any of the following: cardiovascular death, myocardial infarction, emergency revascularisation, hospitalisation with unstable angina. The outcome will be assessed by: 1) Notification to the transplant coordinators when patients are admitted in hospital (this is the usual standard of care in wait-listed patients). 2) The trial coordinator will gather electronic medical records, letters. procedure notes and .... Read more
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