Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates
NCT ID: NCT03674307
Last Updated: 2024-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3306 participants
INTERVENTIONAL
2018-12-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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No screening
No further screening for asymptomatic coronary artery disease after wait-list entry
No screening
No further screening for asymptomatic coronary artery disease after wait-list entry
Regular screening
Regular (yearly or 2nd yearly) 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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University of Sydney
OTHER
University of British Columbia
OTHER
Responsible Party
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John Gill
Professor of Medicine
Principal Investigators
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Jagbir Gill, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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University of Arizona
Tucson, Arizona, United States
The George Washington University
Washington D.C., District of Columbia, United States
University of Alberta
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
Dalhousie University
Halifax, Nova Scotia, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Kingston Health Science Centre
Kingston, Ontario, Canada
London Health Science Centre
London, Ontario, Canada
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
CHU de Quebec-Universite Laval's L'Hotel-Dieu de Quebec
Laval, Quebec, Canada
University of Montreal, Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Universite de Montreal, Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
St. Paul's Hospital, University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Charité Universitätsmedizin
Berlin, , Germany
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 Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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H16-01335_CARSK
Identifier Type: -
Identifier Source: org_study_id
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