Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates

Last updated: May 10, 2024
Sponsor: University of British Columbia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Heart Disease

Thrombosis

Treatment

Regular Screening

No screening

Clinical Study ID

NCT03674307
H16-01335_CARSK
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. adults aged 18 years of age or older

  2. Dialysis-dependent kidney failure and currently being assessed for OR active on thekidney transplant waiting list

  3. expected to require further screening for CAD prior to transplantation (by currentstandard of care);

  4. able to give consent;

  5. anticipated to undergo transplantation more than 12 months from date of enrolment

Exclusion

Exclusion Criteria:

  1. patients with signs or symptoms suggestive of uncontrolled cardiac disease such asunstable 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

Total Participants: 3306
Treatment Group(s): 2
Primary Treatment: Regular Screening
Phase:
Study Start date:
December 01, 2018
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University of Alberta

    Edmonton, Alberta
    Canada

    Active - Recruiting

  • University of British Columbia

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Active - Recruiting

  • Dalhousie University

    Halifax, Nova Scotia B3H 1V8
    Canada

    Active - Recruiting

  • St. Joseph's Healthcare

    Hamilton, Ontario L8N 4A6
    Canada

    Active - Recruiting

  • Kingston Health Science Centre

    Kingston, Ontario
    Canada

    Active - Recruiting

  • London Health Science Centre

    London, Ontario
    Canada

    Active - Recruiting

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario K1H 7W9
    Canada

    Active - Recruiting

  • St Michael's Hospital

    Toronto, Ontario
    Canada

    Active - Recruiting

  • University Health Network

    Toronto, Ontario M5G 2N2
    Canada

    Active - Recruiting

  • CHU de Quebec-Universite Laval's L'Hotel-Dieu de Quebec

    Laval, Quebec
    Canada

    Active - Recruiting

  • McGill University Health Centre

    Montréal, Quebec
    Canada

    Active - Recruiting

  • Universite de Montreal, Hopital Maisonneuve-Rosemont

    Montréal, Quebec
    Canada

    Active - Recruiting

  • University of Montreal, Maisonneuve-Rosemont Hospital

    Montréal, Quebec H1T 2M4
    Canada

    Active - Recruiting

  • St. Paul's Hospital, University of Saskatchewan

    Saskatoon, Saskatchewan
    Canada

    Active - Recruiting

  • Charité Universitätsmedizin

    Berlin,
    Germany

    Site Not Available

  • Sussex Brighton R&D

    Brighton, BN2 1ES
    United Kingdom

    Active - Recruiting

  • King's College Hospital NHS Foundation Trust

    Brixton, SW9 8RR
    United Kingdom

    Active - Recruiting

  • Epsom and St Helier University Hospitals NHS Trust

    Carshalton, SM5 1AA
    United Kingdom

    Active - Recruiting

  • Barts Health NHS Trust

    London, E1 4UJ
    United Kingdom

    Active - Recruiting

  • St George's University Hospital NHS Trust Foundation

    London,
    United Kingdom

    Site Not Available

  • University of Arizona

    Tucson, Arizona 85724
    United States

    Active - Recruiting

  • The George Washington University

    Washington, District of Columbia 20052
    United States

    Active - Recruiting

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