No Screening
OtherNo further screening for asymptomatic coronary artery disease after wait-list entry
NCT Number: NCT03674307
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
University of Alberta, Edmonton, Alberta, Canada
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No further screening for asymptomatic coronary artery disease after wait-list entry
Annual or second-yearly screening for asymptomatic coronary artery disease after wait-list entry
Time frame: 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:
Time frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
Death due to any cause
Time frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
Urgent, symptom-driven revascularisation for coronary artery disease
Time frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
Stroke
Time frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
health related quality of life as measured by EQ5D and/or KDQOL 36
Time frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
Time off the wait-list
Time frame: The analysis will take place at the end of the study. This outcome will be followed up for 5 years.
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.
Time frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
incidence of transplantation between the two arms
Time frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
incidence of permanent removal from the wait list due to cardiac causes between the two arms
Time frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
incidence of cancellation of transplantation due to coronary artery disease
Time frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
incidence of cardiovascular death
University of British Columbia
Other
Canadian-Australasian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease
Acronym: CARSK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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