Cardiovascular Diseases Clinical Trial
— CARSKOfficial title:
Canadian-Australasian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease
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.
Status | Recruiting |
Enrollment | 3306 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Canada | Dalhousie University | Halifax | Nova Scotia |
Canada | St. Joseph's Healthcare | Hamilton | Ontario |
Canada | Kingston Health Science Centre | Kingston | Ontario |
Canada | CHU de Quebec-Universite Laval's L'Hotel-Dieu de Quebec | Laval | Quebec |
Canada | London Health Science Centre | London | Ontario |
Canada | McGill University Health Centre | Montréal | Quebec |
Canada | Universite de Montreal, Hopital Maisonneuve-Rosemont | Montréal | Quebec |
Canada | University of Montreal, Maisonneuve-Rosemont Hospital | Montréal | Quebec |
Canada | The Ottawa Hospital Research Institute | Ottawa | Ontario |
Canada | St. Paul's Hospital, University of Saskatchewan | Saskatoon | Saskatchewan |
Canada | St Michael's Hospital | Toronto | Ontario |
Canada | University Health Network | Toronto | Ontario |
Canada | University of British Columbia | Vancouver | British Columbia |
Germany | Charité Universitätsmedizin | Berlin | |
United Kingdom | 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 | London | |
United States | University of Arizona | Tucson | Arizona |
United States | The George Washington University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | University of Sydney |
United States, Canada, Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MACE | 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: Notification to the transplant coordinators when patients are admitted in hospital (this is the usual standard of care in waitlisted patients). 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. Patients will be followed up 6-monthly (alternating by phone and clinic visits) where trial coordinators will discuss any hospitalisation with the patients. |
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. | |
Secondary | All-cause death | Death due to any cause | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant | |
Secondary | Emergency revascularisation | Urgent, symptom-driven revascularisation for coronary artery disease | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant | |
Secondary | Stroke | Stroke | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant | |
Secondary | Health related quality of life | health related quality of life as measured by EQ5D and/or KDQOL 36 | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant | |
Secondary | Time of wait-listing | Time off the wait-list | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant | |
Secondary | Cost effectiveness | Economic evaluation of the cost effectiveness of the trial from a health system perspective.
Data on resource use will be obtained in two ways. First through identification of tests, procedures and doctor's visits related to cardiac and renal management for all study participants from randomisation to study end as recorded in the patient diaries and trial case report forms. Second, Australian participants will have their records linked to the Admitted Patient Data Collection, Emergency Department Data Collection, and through Medicare for all Medicare Benefits Schedule (MBS) outpatient visits, procedures and the Pharmaceutical Benefits Scheme (PBS) for medicines. |
The analysis will take place at the end of the study. This outcome will be followed up for 5 years. | |
Secondary | Incidence of transplantation | incidence of transplantation between the two arms | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant | |
Secondary | Incidence of permanent removal from wait list for cardiac causes | incidence of permanent removal from the wait list due to cardiac causes between the two arms | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant | |
Secondary | Cancellation of transplantation due to coronary artery disease | incidence of cancellation of transplantation due to coronary artery disease | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant | |
Secondary | Cardiovascular death | incidence of cardiovascular death | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant |
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