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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03674307
Other study ID # H16-01335_CARSK
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source University of British Columbia
Contact Breanna Riou-Green
Phone 1-604-682-2344
Email aogniben@providencehealth.bc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Other:
No screening
No further screening for asymptomatic coronary artery disease after wait-list entry
Regular Screening
Annual or second-yearly screening for asymptomatic coronary artery disease after wait-list entry

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia University of Sydney

Countries where clinical trial is conducted

United States,  Canada,  Germany,  United Kingdom, 

Outcome

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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