Cardiovascular DiseasesEnd Stage Renal DiseaseKidney TransplantationDialysis Related Complication
Investigational drug(s) / intervention(s)
No screeningRegular Screening
No screening: No further screening for asymptomatic coronary artery disease after wait-list entry
Regular Screening: Annual or second-yearly screening for asymptomatic coronary artery disease after wait-list entry
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
MACE — The investigators will analyse time to first MACE event for the duration of the trial (60 months), depending on patient's date of transplant. Follow-up will be 12 months posttransplant. Maximum follow-up is 72 months. 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 waitlisted patients).
2. The trial coordinator will gather electronic medical records, letters, procedure notes, and will fill in the relevant case record form on the REDCap database (managed by Sydney local health district). All data are encrypted and stored on servers at SLHD, where it is backed up.
3. Patients will be followed up 6-monthly (alternating by phone and clinic visits) where trial coordinators will discuss any hospitalisation with the patients.
Trial sites (22)
Facility
City
Region
Status
University of Arizona
Tucson
Arizona
The George Washington University
Washington D.C.
District of Columbia
University of Alberta
Edmonton
Alberta
University of British Columbia
Vancouver
British Columbia
Dalhousie University
Halifax
Nova Scotia
St. Joseph's Healthcare
Hamilton
Ontario
Kingston Health Science Centre
Kingston
Ontario
London Health Science Centre
London
Ontario
The Ottawa Hospital Research Institute
Ottawa
Ontario
University Health Network
Toronto
Ontario
St Michael's Hospital
Toronto
Ontario
CHU de Quebec-Universite Laval's L'Hotel-Dieu de Quebec
Laval
Quebec
University of Montreal, Maisonneuve-Rosemont Hospital
Montreal
Quebec
McGill University Health Centre
Montreal
Quebec
Universite de Montreal, Hopital Maisonneuve-Rosemont
Montreal
Quebec
St. Paul's Hospital, University of Saskatchewan
Saskatoon
Saskatchewan
Charité Universitätsmedizin
Berlin
Germany
Sussex Brighton R&D
Brighton
United Kingdom
King's College Hospital NHS Foundation Trust
Brixton
United Kingdom
Epsom and St Helier University Hospitals NHS Trust
Carshalton
United Kingdom
Barts Health NHS Trust
London
United Kingdom
St George's University Hospital NHS Trust Foundation
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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