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NCT Number: NCT03674307

Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates

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.

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Key information

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

  • 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.
  • Compare the benefits and costs of not screening versus regular CAD screening from a health system perspective.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults aged 18 years of age or older
  • Dialysis-dependent kidney failure and currently being assessed for OR active on the kidney transplant waiting list
  • expected to require further screening for CAD prior to transplantation (by current standard of care);
  • able to give consent;
  • anticipated to undergo transplantation more than 12 months from date of enrolment

Exclusion criteria

  • 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;
  • patients who "on-hold" for transplantation due to a medical problem;
  • patients with other solid organ transplants;
  • multi-organ transplant candidates (e.g. kidney-pancreas transplant candidates);
  • patients with planned living donor transplant;
  • patients unable to give consent.

Treatment and study plan

No Screening

Other

No further screening for asymptomatic coronary artery disease after wait-list entry

Regular Screening

Other

Annual or second-yearly screening for asymptomatic coronary artery disease after wait-list entry

Primary outcomes

  1. MACE

    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:

    • 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.

Secondary outcomes

  1. All-cause death

    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

  2. Emergency revascularisation

    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

  3. Stroke

    Time frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant

    Stroke

  4. Health related quality of life

    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

  5. Time of wait-listing

    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

  6. Cost effectiveness

    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.

  7. Incidence of transplantation

    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

  8. Incidence of permanent removal from wait list for cardiac causes

    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

  9. 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 cancellation of transplantation due to coronary artery disease

  10. Cardiovascular death

    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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • University of Sydney

Registry information

Official study title

Canadian-Australasian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease

Acronym: CARSK

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Sep 17, 2018
Registry last updated
Jul 6, 2026

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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