Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates (CARSK)
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| ClinicalTrials.gov Identifier: NCT03674307 |
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Recruitment Status :
Recruiting
First Posted : September 17, 2018
Last Update Posted : November 7, 2022
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| 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 |
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
- 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.
- Compare the benefits and costs of not screening versus regular CAD screening from a health system perspective.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: No screening
No further screening for asymptomatic coronary artery disease after wait-list entry
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Other: No screening
No further screening for asymptomatic coronary artery disease after wait-list entry |
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Active Comparator: Regular screening
Regular (yearly or 2nd yearly) screening for asymptomatic coronary artery disease after wait-list entry
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Other: Regular Screening
Annual or second-yearly screening for asymptomatic coronary artery disease after wait-list entry |
- 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:
- Notification to the transplant coordinators when patients are admitted in hospital (this is the usual standard of care in waitlisted patients).
- 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.
- Patients will be followed up 6-monthly (alternating by phone and clinic visits) where trial coordinators will discuss any hospitalisation with the patients.
- 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
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adults aged 18 years of age or older
- Dialysis-dependent kidney failure and currently being assessed for OR active on the kidney transplant waiting list
- expected to require further screening for CAD prior to transplantation (by current standard of care);
- able to give consent;
- anticipated to undergo transplantation more than 12 months from date of enrolment
Exclusion Criteria:
- 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;
- patients who "on-hold" for transplantation due to a medical problem;
- patients with other solid organ transplants;
- multi-organ transplant candidates (e.g. kidney-pancreas transplant candidates);
- patients with planned living donor transplant;
- patients unable to give consent.
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
| 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 |
Show 22 study locations
| Principal Investigator: | Jagbir Gill, MD | University of British Columbia |
Documents provided by John Gill, University of British Columbia:
| Responsible Party: | John Gill, Professor of Medicine, 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: | November 7, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Kidney Failure, Chronic Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Kidney Diseases |
Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Renal Insufficiency, Chronic Renal Insufficiency Chronic Disease Disease Attributes Pathologic Processes |