Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates (CARSK)

November 4, 2022 updated by: John Gill, University of British Columbia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

  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.

Study Type

Interventional

Enrollment (Anticipated)

3306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V8
        • Recruiting
        • Dalhousie University
        • Principal Investigator:
          • Amanda Vinson, MD
        • Contact:
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • St. Joseph's Healthcare
        • Contact:
        • Principal Investigator:
          • Christine Ribic, MD
      • Kingston, Ontario, Canada
        • Recruiting
        • Kingston Health Science Centre
        • Contact:
        • Principal Investigator:
          • Mohammad Khaled Shamseddin
      • London, Ontario, Canada
        • Recruiting
        • London Health Science Centre
        • Principal Investigator:
          • Anthony Jevnikar, MD
        • Contact:
        • Principal Investigator:
          • Lakshman Gunaratnam, MD
      • Ottawa, Ontario, Canada, K1H 7W9
        • Recruiting
        • The Ottawa Hospital Research Institute
        • Principal Investigator:
          • Greg Knoll, MD
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M5G 2N2
        • Recruiting
        • University Health Network
        • Contact:
        • Principal Investigator:
          • S. Joseph Kim, MD
      • Toronto, Ontario, Canada
        • Recruiting
        • St Michael's Hospital
        • Contact:
        • Principal Investigator:
          • Ramesh Prasad, MD
    • Quebec
      • Laval, Quebec, Canada
        • Recruiting
        • CHU de Quebec-Universite Laval's L'Hotel-Dieu de Quebec
        • Contact:
        • Principal Investigator:
          • Sacha DeSerres
      • Montréal, Quebec, Canada
        • Recruiting
        • McGill University Health Centre
        • Contact:
        • Principal Investigator:
          • Marcelo Cantarovich, MD
      • Montréal, Quebec, Canada, H1T 2M4
        • Recruiting
        • University of Montreal, Maisonneuve-Rosemont Hospital
        • Contact:
        • Principal Investigator:
          • Duy Tran, MD
      • Montréal, Quebec, Canada
        • Recruiting
        • Universite de Montreal, Hopital Maisonneuve-Rosemont
        • Contact:
        • Principal Investigator:
          • Heloise Cardinal, MD
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Recruiting
        • St. Paul's Hospital, University of Saskatchewan
        • Contact:
        • Principal Investigator:
          • Rahul Mainra, MD
  • Germany
      • Berlin, Germany
  • United Kingdom
      • Brighton, United Kingdom, BN2 1ES
        • Recruiting
        • Sussex Brighton R&D
        • Contact:
        • Principal Investigator:
          • Kostantinos Koutroutsos
      • Brixton, United Kingdom, SW9 8RR
        • Recruiting
        • King's College Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Shah Sapna
      • Carshalton, United Kingdom, SM5 1AA
        • Recruiting
        • Epsom and St Helier University Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Mysore Phanish
      • London, United Kingdom, E1 4UJ
        • Recruiting
        • Barts Health NHS Trust
        • Principal Investigator:
          • Kieran McCafferty
        • Contact:
      • London, United Kingdom
        • Not yet recruiting
        • St George's University Hospital NHS Trust Foundation
        • Contact:
        • Principal Investigator:
          • Debasish Bannerjee, MD
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona
        • Contact:
        • Principal Investigator:
          • Ariyamuthu Venkatesh
    • District of Columbia
      • Washington, District of Columbia, United States, 20052
        • Recruiting
        • The George Washington University
        • Contact:
        • Principal Investigator:
          • Dominic Raj

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No screening
No further screening for asymptomatic coronary artery disease after wait-list entry
Other: No screening
No further screening for asymptomatic coronary artery disease after wait-list entry
Active Comparator: Regular screening
Regular (yearly or 2nd yearly) screening for asymptomatic coronary artery disease after wait-list entry
Other: Regular Screening
Annual or second-yearly screening for asymptomatic coronary artery disease after wait-list entry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

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

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.
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
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
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
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
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
incidence of cardiovascular death
Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

University of Sydney

Investigators

  • Principal Investigator: Jagbir Gill, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (Actual)

September 17, 2018

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H16-01335_CARSK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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