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| Name | Class |
|---|---|
| University of Sydney | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No screening | Experimental | No further screening for asymptomatic coronary artery disease after wait-list entry |
|
| Regular screening | Active Comparator | Regular (yearly or 2nd yearly) screening for asymptomatic coronary artery disease after wait-list entry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No screening | Other | No further screening for asymptomatic coronary artery disease after wait-list entry |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACE | 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:
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | Death due to any cause | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant |
| Emergency revascularisation | Urgent, symptom-driven revascularisation for coronary artery disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jagbir Gill, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States | ||
| The George Washington University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31228771 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 28, 2018 | Aug 29, 2018 |
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| Regular Screening | Other | Annual or second-yearly screening for asymptomatic coronary artery disease after wait-list entry |
|
| Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant |
| Stroke | Stroke | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant |
| Health related quality of life | health related quality of life as measured by EQ5D and/or KDQOL 36 | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant |
| Time of wait-listing | Time off the wait-list | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant |
| Cost effectiveness | 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. | The analysis will take place at the end of the study. This outcome will be followed up for 5 years. |
| Incidence of transplantation | incidence of transplantation between the two arms | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant |
| Incidence of permanent removal from wait list for cardiac causes | incidence of permanent removal from the wait list due to cardiac causes between the two arms | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant |
| Cancellation of transplantation due to coronary artery disease | incidence of cancellation of transplantation due to coronary artery disease | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant |
| Cardiovascular death | incidence of cardiovascular death | Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant |
| Washington D.C. |
| District of Columbia |
| 20052 |
| United States |
| University of Alberta | Edmonton | Alberta | Canada |
| University of British Columbia | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Dalhousie University | Halifax | Nova Scotia | B3H 1V8 | Canada |
| St. Joseph's Healthcare | Hamilton | Ontario | L8N 4A6 | Canada |
| Kingston Health Science Centre | Kingston | Ontario | Canada |
| London Health Science Centre | London | Ontario | Canada |
| The Ottawa Hospital Research Institute | Ottawa | Ontario | K1H 7W9 | Canada |
| University Health Network | Toronto | Ontario | M5G 2N2 | 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 | H1T 2M4 | 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 | BN2 1ES | United Kingdom |
| King's College Hospital NHS Foundation Trust | Brixton | SW9 8RR | United Kingdom |
| Epsom and St Helier University Hospitals NHS Trust | Carshalton | SM5 1AA | United Kingdom |
| Barts Health NHS Trust | London | E1 4UJ | United Kingdom |
| St George's University Hospital NHS Trust Foundation | London | United Kingdom |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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