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

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ClinicalTrials.gov Identifier: NCT03674307
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
John Gill, University of British Columbia

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE September 17, 2018
Last Update Posted Date April 30, 2021
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
MACE [ Time Frame: We 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
  • 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
  • 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
  • Stroke [ Time Frame: Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant ]
    Stroke
  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates
Official Title  ICMJE Canadian-Australasian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Cardiovascular Diseases
  • End Stage Renal Disease
  • Kidney Transplantation
  • Dialysis Related Complication
Intervention  ICMJE
  • Other: No screening
    No further 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
Study Arms  ICMJE
  • Experimental: No screening
    No further screening for asymptomatic coronary artery disease after wait-list entry
    Intervention: Other: No screening
  • Active Comparator: Regular screening
    Regular (yearly or 2nd yearly) screening for asymptomatic coronary artery disease after wait-list entry
    Intervention: Other: Regular Screening
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2018)
3306
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Angela Ogniben 1-604-682-2344 ext 64707 aogniben@providencehealth.bc.ca
Contact: Breanna Riou-Green 1-604-682-2344 ext 64708 Briougreen@providencehealth.bc.ca
Listed Location Countries  ICMJE Canada,   Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03674307
Other Study ID Numbers  ICMJE H16-01335_CARSK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party John Gill, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE University of Sydney
Investigators  ICMJE
Principal Investigator: Jagbir Gill, MD University of British Columbia
PRS Account University of British Columbia
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP