TrialPath
← Back to searchRecruiting

Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates

NCT03674307 · University of British Columbia
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Canadian-Australasian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 3306 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2018-12-01
Estimated completion: 2025-12-31
Last updated: 2024-05-13
Interventions
Other: No screeningOther: Regular Screening
Primary outcomes
  • 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.)
Sponsor
University of British Columbia · other
With: University of Sydney
Contacts & investigators
ContactBreanna Riou-Green · contact · aogniben@providencehealth.bc.ca · 1-604-682-2344
ContactGurvir Thind · contact · Briougreen@providencehealth.bc.ca · 1-604-682-2344
InvestigatorJagbir Gill, MD · principal_investigator, University of British Columbia
All locations (22)
University of ArizonaRecruiting
Tucson, Arizona, United States
The George Washington UniversityRecruiting
Washington D.C., District of Columbia, United States
University of AlbertaRecruiting
Edmonton, Alberta, Canada
University of British ColumbiaRecruiting
Vancouver, British Columbia, Canada
Dalhousie UniversityRecruiting
Halifax, Nova Scotia, Canada
St. Joseph's HealthcareRecruiting
Hamilton, Ontario, Canada
Kingston Health Science CentreRecruiting
Kingston, Ontario, Canada
London Health Science CentreRecruiting
London, Ontario, Canada
The Ottawa Hospital Research InstituteRecruiting
Ottawa, Ontario, Canada
University Health NetworkRecruiting
Toronto, Ontario, Canada
St Michael's HospitalRecruiting
Toronto, Ontario, Canada
CHU de Quebec-Universite Laval's L'Hotel-Dieu de QuebecRecruiting
Laval, Quebec, Canada
University of Montreal, Maisonneuve-Rosemont HospitalRecruiting
Montreal, Quebec, Canada
McGill University Health CentreRecruiting
Montreal, Quebec, Canada
Universite de Montreal, Hopital Maisonneuve-RosemontRecruiting
Montreal, Quebec, Canada
St. Paul's Hospital, University of SaskatchewanRecruiting
Saskatoon, Saskatchewan, Canada
Charité UniversitätsmedizinNot Yet Recruiting
Berlin, Germany
Sussex Brighton R&DRecruiting
Brighton, United Kingdom
King's College Hospital NHS Foundation TrustRecruiting
Brixton, United Kingdom
Epsom and St Helier University Hospitals NHS TrustRecruiting
Carshalton, United Kingdom
Barts Health NHS TrustRecruiting
London, United Kingdom
St George's University Hospital NHS Trust FoundationNot Yet Recruiting
London, United Kingdom
Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates · TrialPath