Cardiovascular DiseasesCARSKNCT03674307
Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates
A study testing No screening and Regular Screening in people with Cardiovascular Diseases and End Stage Renal Disease, run by University of British Columbia at 22 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, End Stage Renal Disease, Kidney Transplantation
- What is being tested?
- No screening and Regular Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,306 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 1 Dec 2018to 26 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
Canada14 sites
University of Alberta
Edmonton, Alberta
Dalhousie University
Halifax, Nova Scotia, B3H 1V8
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
Kingston Health Science Centre
Kingston, Ontario
CHU de Quebec-Universite Laval's L'Hotel-Dieu de Quebec
Laval, Quebec
London Health Science Centre
London, Ontario
University of Montreal, Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
McGill University Health Centre
Montreal, Quebec
Universite de Montreal, Hopital Maisonneuve-Rosemont
Montreal, Quebec
The Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 7W9
St. Paul's Hospital, University of Saskatchewan
Saskatoon, Saskatchewan
University Health Network
Toronto, Ontario, M5G 2N2
St Michael's Hospital
Toronto, Ontario
University of British Columbia
Vancouver, British Columbia, V6Z 1Y6
United Kingdom5 sites
Sussex Brighton R&D
Brighton, BN2 1ES
King's College Hospital NHS Foundation Trust
Brixton, SW9 8RR
Epsom and St Helier University Hospitals NHS Trust
Carshalton, SM5 1AA
Barts Health NHS Trust
London, E1 4UJ
St George's University Hospital NHS Trust Foundation
London
United States2 sites
University of Arizona
Tucson, Arizona, 85724
The George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official 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.
Read the detailed description
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.
- Conditions
- Cardiovascular Diseases, End Stage Renal Disease, Kidney Transplantation, Dialysis Related Complication
- Being tested
- No screening, Regular Screening
- Medical subject headings
- Cardiovascular Diseases, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No screeningOther
No further screening for asymptomatic coronary artery disease after wait-list entry
Regular ScreeningOther
Annual or second-yearly screening for asymptomatic coronary artery disease after wait-list entry
| Study group | Role | What they receive |
|---|---|---|
| No screening | Experimental | No further screening for asymptomatic coronary artery disease after wait-list entry Receives: Other: No screening |
| Regular screening | Active comparator | Regular (yearly or 2nd yearly) screening for asymptomatic coronary artery disease after wait-list entry Receives: Other: Regular Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (10)
All-cause death
Death due to any cause
Measured: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
Emergency revascularisation
Urgent, symptom-driven revascularisation for coronary artery disease
Measured: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
Stroke
Stroke
Measured: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
Health related quality of life
health related quality of life as measured by EQ5D and/or KDQOL 36
Measured: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
Time of wait-listing
Time off the wait-list
Measured: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
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.
Measured: The analysis will take place at the end of the study. This outcome will be followed up for 5 years.
Incidence of transplantation
incidence of transplantation between the two arms
Measured: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
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
Measured: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
Cancellation of transplantation due to coronary artery disease
incidence of cancellation of transplantation due to coronary artery disease
Measured: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
Cardiovascular death
incidence of cardiovascular death
Measured: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start1 Dec 2018
- Primary completion26 Jan 2028 (estimated)
- Study completion26 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,306 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney
- Responsible party
- Principal investigator, John Gill, University of British Columbia
- Investigators
- Jagbir Gill, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674307
- Sponsor's protocol ID
- H16-01335_CARSK
- Acronym
- CARSK
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2018
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ying T, Gill J, Webster A, Kim SJ, Morton R, Klarenbach SW, Kelly P, Ramsay T, Knoll GA, Pilmore H, Hughes G, Herzog CA, Chadban S, Gill JS. Canadian-Australasian Randomised trial of screening kidney transplant candidates for coronary artery disease-A trial protocol for the CARSK study. Am Heart J. 2019 Aug;214:175-183. doi: 10.1016/j.ahj.2019.05.008. Epub 2019 May 22.
PubMed 31228771
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian-Australasian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03674307
- Acronym / sponsor ID
- CARSK / H16-01335_CARSK
- Conditions
- Cardiovascular Diseases, End Stage Renal Disease, Kidney Transplantation, Dialysis Related Complication
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,306 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of Sydney
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 26 Jan 2028 (estimated)
- Study completion
- 26 Jan 2028 (estimated)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No screening | Experimental | Other: No screeningNo further screening for asymptomatic coronary artery disease after wait-list entry |
| Regular screening | Active comparator | Other: Regular ScreeningRegular (yearly or 2nd yearly) screening for asymptomatic coronary artery disease after wait-list entry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No screeningNo further screening for asymptomatic coronary artery disease after wait-list entry | Other | No screening |
| Regular ScreeningAnnual or second-yearly screening for asymptomatic coronary artery disease after wait-list entry | Other | Regular screening |
Primary outcome
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: 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.
10 secondary outcomes
All-cause death
Time frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
Emergency revascularisation
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
Time frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
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
Cost effectiveness
Time frame: The analysis will take place at the end of the study. This outcome will be followed up for 5 years.
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 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
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
Cardiovascular death
Time frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 31228771Ying T, Gill J, Webster A, Kim SJ, Morton R, Klarenbach SW, Kelly P, Ramsay T, Knoll GA, Pilmore H, Hughes G, Herzog CA, Chadban S, Gill JS. Canadian-Australasian Randomised trial of screening kidney transplant candidates for coronary artery disease-A trial protocol for the CARSK study. Am Heart J. 2019 Aug;214:175-183. doi: 10.1016/j.ahj.2019.05.008. Epub 2019 May 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jagbir Gill, MD principal investigator
University of British Columbia
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No screening and Regular Screening in people with Cardiovascular Diseases and End Stage Renal Disease, run by University of British Columbia at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Canada, United Kingdom, United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03674307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.