Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674307
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
John Gill, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases End Stage Renal Disease Kidney Transplantation Dialysis Related Complication Other: No screening Other: Regular Screening Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Canadian-Australasian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

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

  4. 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

  5. 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

  6. 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.


  7. 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

  8. 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

  9. 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

  10. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674307


Contacts
Layout table for location contacts
Contact: Gillian Hughes 1-780-782-4455 ghughes1@providencehealth.bc.ca
Contact: Breanna Riou-Green 1-604-682-2344 ext 64708 Briougreen@providencehealth.bc.ca

Locations
Layout table for location information
United States, District of Columbia
The George Washington University Recruiting
Washington, District of Columbia, United States, 20052
Contact: Danielle Kincaid       dkincaid@mfa.gwu.edu   
Sub-Investigator: Dominic Raj         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6Z 2K8
Contact: Breanna Riou-Green    1-604-682-2344 ext 64708    Briougreen@providencehealth.bc.ca   
Contact: Cameron Houchmand       chouchmand@providencehealth.bc.ca   
Principal Investigator: Jagbir S Gill, MD         
Sub-Investigator: John S Gill, MD         
Canada, Nova Scotia
Dalhousie University Recruiting
Halifax, Nova Scotia, Canada, B3H 1V8
Contact: Laura Sills    1-902-473-7625    laura.sills@nshealth.ca   
Principal Investigator: Amanda Vinson, MD         
Canada, Ontario
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Andrea Mazetti    1-905-522-1155 ext 35368    amazzett@stjosham.on.ca   
Principal Investigator: Christine Ribic, MD         
London Health Science Centre Recruiting
London, Ontario, Canada
Contact: Samantha Parsons    519-685-8500 ext 34755    Samantha.parsons@lhsc.on.ca   
Principal Investigator: Lakshman Gunaratnam, MD         
Principal Investigator: Anthony Jevnikar, MD         
The Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 7W9
Contact: Erin Thomas    1-613-738-8400 ext 81622    erithomas@toh.ca   
Contact: Julie Leidecker       jleidecker@ohri.ca   
Principal Investigator: Greg Knoll, MD         
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Michelle Minkovich    1-416-340-4800 ext 2012    Michelle.Minkovich@uhnresearch.ca   
Principal Investigator: S. Joseph Kim, MD         
St Michael's Hospital Recruiting
Toronto, Ontario, Canada
Contact: Michelle Nash    416-867-3692    michelle.nash@unityhealth.to   
Principal Investigator: Ramesh Prasad, MD         
Canada, Quebec
CHU de Quebec-Universite Laval's L'Hotel-Dieu de Quebec Not yet recruiting
Laval, Quebec, Canada
Contact: France Samson         
Principal Investigator: Sacha DeSerres         
University of Montreal Recruiting
Montréal, Quebec, Canada, H1T 2M4
Contact: Lucie Boutin    1-514-252-3400 ext 6500    lboutin.hmr@ssss.gouv.qc.ca   
Principal Investigator: Duy Tran, MD         
McGill University Health Centre Recruiting
Montréal, Quebec, Canada
Contact: Cristina Al Ali    514-934-1934 ext 36223    Cristina.Al-Ali@MUHC.MCGILL.CA   
Contact: Ayat Salman       Ayat.Salman@muhc.mcgill.ca   
Principal Investigator: Marcelo Cantarovich, MD         
Universite de Montreal, Hopital Maisonneuve-Rosemont Recruiting
Montréal, Quebec, Canada
Contact: Majda Belkaid    514 890-8000 ext 28241    majda.belkaid.chum@ssss.gouv.qc.ca   
Principal Investigator: Heloise Cardinal, MD         
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada
Contact: Adeola Adesokan    306-978-8306    adeola.adesokan@usask.ca   
Principal Investigator: Rahul Mainra, MD         
Germany
Charité Universitätsmedizin Not yet recruiting
Berlin, Germany
Contact: Martina Bertolo       martina.bertolo@charite.de   
Sub-Investigator: Klemens Budde         
United Kingdom
St George's University Hospital NHS Trust Foundation Not yet recruiting
London, United Kingdom
Contact: Debasish Bannerjee, MD       Debasish.Banerjee@stgeorges.nhs.uk   
Sub-Investigator: Debasish Bannerjee, MD         
Sponsors and Collaborators
University of British Columbia
University of Sydney
Investigators
Layout table for investigator information
Principal Investigator: Jagbir Gill, MD University of British Columbia
  Study Documents (Full-Text)

Documents provided by John Gill, University of British Columbia:
Study Protocol  [PDF] August 28, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: John Gill, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03674307    
Other Study ID Numbers: H16-01335_CARSK
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Failure, Chronic
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency