Screening for heart disease in kidney transplant candidates
Canadian-Australasian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease
NA · University of British Columbia · NCT03674307
This study is testing if skipping regular heart disease screenings for people on the kidney transplant waiting list is just as safe and effective as continuing those screenings.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 3306 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of British Columbia (other) |
| Locations | 22 sites (Tucson, Arizona and 21 other locations) |
| Trial ID | NCT03674307 on ClinicalTrials.gov |
What this trial studies
The CARSK study aims to evaluate whether eliminating regular non-invasive screening tests for coronary artery disease (CAD) after kidney transplant waitlist activation is as effective as the current standard of annual screening. This study focuses on patients with end-stage renal disease who are either being assessed for or are active on the kidney transplant waiting list. It will compare the outcomes of patients who receive no further screening after initial assessment to those who continue with regular screenings, with a focus on preventing major adverse cardiac events and assessing the cost-effectiveness of the screening approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are dialysis-dependent and currently assessed for or active on the kidney transplant waiting list.
Not a fit: Patients with uncontrolled cardiac disease or those on hold for transplantation due to medical issues will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more efficient and less costly approach to screening kidney transplant candidates, potentially improving patient outcomes.
How similar studies have performed: While the approach of eliminating routine screening is novel, existing studies have highlighted the importance of addressing cardiovascular risks in kidney transplant candidates, suggesting potential for meaningful advancements.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tucson, Arizona and 21 other locations
- University of Arizona — Tucson, Arizona, United States (RECRUITING)
- The George Washington University — Washington D.C., District of Columbia, United States (RECRUITING)
- University of Alberta — Edmonton, Alberta, Canada (RECRUITING)
- University of British Columbia — Vancouver, British Columbia, Canada (RECRUITING)
- Dalhousie University — Halifax, Nova Scotia, Canada (RECRUITING)
- St. Joseph's Healthcare — Hamilton, Ontario, Canada (RECRUITING)
- Kingston Health Science Centre — Kingston, Ontario, Canada (RECRUITING)
- London Health Science Centre — London, Ontario, Canada (RECRUITING)
- The Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (RECRUITING)
- University Health Network — Toronto, Ontario, Canada (RECRUITING)
- St Michael's Hospital — Toronto, Ontario, Canada (RECRUITING)
- CHU de Quebec-Universite Laval's L'Hotel-Dieu de Quebec — Laval, Quebec, Canada (RECRUITING)
- University of Montreal, Maisonneuve-Rosemont Hospital — Montreal, Quebec, Canada (RECRUITING)
- McGill University Health Centre — Montreal, Quebec, Canada (RECRUITING)
- Universite de Montreal, Hopital Maisonneuve-Rosemont — Montreal, Quebec, Canada (RECRUITING)
- St. Paul's Hospital, University of Saskatchewan — Saskatoon, Saskatchewan, Canada (RECRUITING)
- Charité Universitätsmedizin — Berlin, Germany (NOT_YET_RECRUITING)
- Sussex Brighton R&D — Brighton, United Kingdom (RECRUITING)
- King's College Hospital NHS Foundation Trust — Brixton, United Kingdom (RECRUITING)
- Epsom and St Helier University Hospitals NHS Trust — Carshalton, United Kingdom (RECRUITING)
- Barts Health NHS Trust — London, United Kingdom (RECRUITING)
- St George's University Hospital NHS Trust Foundation — London, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Jagbir Gill, MD — University of British Columbia
- Study coordinator: Breanna Riou-Green
- Email: aogniben@providencehealth.bc.ca
- Phone: 1-604-682-2344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiovascular Diseases, End Stage Renal Disease, Kidney Transplantation, Dialysis Related Complication