None listed
Conditions
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.
Interventions
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
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 years.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed