[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03674307":3,"trial-entities:NCT03674307":243,"trial-summary:NCT03674307":247},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":46,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":81,"eligibility_criteria":82,"std_ages":86,"locations":89,"central_contacts":232,"overall_officials":233,"references":237,"see_also_links":242},"NCT03674307","H16-01335_CARSK","Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates","Canadian-Australasian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease","ACTIVE_NOT_RECRUITING","2028-01-26","2026-07","2026-07-06","2018-12-01","University of British Columbia","OTHER",true,"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.\n\nCARSK aims to\n\n1. 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.\n2. Compare the benefits and costs of not screening versus regular CAD screening from a health system perspective.",[19,20,21,22],"Cardiovascular Diseases","End Stage Renal Disease","Kidney Transplantation","Dialysis Related Complication",[],"INTERVENTIONAL","SCREENING",[27],"NA",{"count":29,"type":30},3306,"ACTUAL",[32,36],{"type":14,"name":33,"description":34,"armGroupLabels":35},"No screening","No further screening for asymptomatic coronary artery disease after wait-list entry",[33],{"type":14,"name":37,"description":38,"armGroupLabels":39},"Regular Screening","Annual or second-yearly screening for asymptomatic coronary artery disease after wait-list entry",[40],"Regular screening",[42],{"measure":43,"description":44,"timeFrame":45},"MACE","Primary efficacy: major adverse cardiac event (MACE), defined as any of the following: cardiovascular death, myocardial infarction, emergency revascularisation, hospitalisation with unstable angina.\n\nThe outcome will be assessed by:\n\n1. Notification to the transplant coordinators when patients are admitted in hospital (this is the usual standard of care in waitlisted patients).\n2. 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.\n3. Patients will be followed up 6-monthly (alternating by phone and clinic visits) where trial coordinators will discuss any hospitalisation with the patients.","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.",[47,51,54,56,59,62,66,69,72,75],{"measure":48,"description":49,"timeFrame":50},"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",{"measure":52,"description":53,"timeFrame":50},"Emergency revascularisation","Urgent, symptom-driven revascularisation for coronary artery disease",{"measure":55,"description":55,"timeFrame":50},"Stroke",{"measure":57,"description":58,"timeFrame":50},"Health related quality of life","health related quality of life as measured by EQ5D and\u002For KDQOL 36",{"measure":60,"description":61,"timeFrame":50},"Time of wait-listing","Time off the wait-list",{"measure":63,"description":64,"timeFrame":65},"Cost effectiveness","Economic evaluation of the cost effectiveness of the trial from a health system perspective.\n\nData 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.",{"measure":67,"description":68,"timeFrame":50},"Incidence of transplantation","incidence of transplantation between the two arms",{"measure":70,"description":71,"timeFrame":50},"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",{"measure":73,"description":74,"timeFrame":50},"Cancellation of transplantation due to coronary artery disease","incidence of cancellation of transplantation due to coronary artery disease",{"measure":76,"description":77,"timeFrame":50},"Cardiovascular death","incidence of cardiovascular death","ALL","18 Years",null,false,{"inclusion":83,"exclusion":84,"raw_text":85},[],[],"Inclusion Criteria:\n\n1. adults aged 18 years of age or older\n2. Dialysis-dependent kidney failure and currently being assessed for OR active on the kidney transplant waiting list\n3. expected to require further screening for CAD prior to transplantation (by current standard of care);\n4. able to give consent;\n5. anticipated to undergo transplantation more than 12 months from date of enrolment\n\nExclusion Criteria:\n\n1. 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;\n2. patients who \"on-hold\" for transplantation due to a medical problem;\n3. patients with other solid organ transplants;\n4. multi-organ transplant candidates (e.g. kidney-pancreas transplant candidates);\n5. patients with planned living donor transplant;\n6. patients unable to give consent.",[87,88],"ADULT","OLDER_ADULT",[90,99,107,115,122,130,138,144,150,157,164,167,174,181,184,187,194,201,209,216,223,229],{"facility":91,"city":92,"state":93,"zip":94,"country":95,"geoPoint":96},"University of Arizona","Tucson","Arizona","85724","United States",{"lat":97,"lon":98},32.22174,-110.92648,{"facility":100,"city":101,"state":102,"zip":103,"country":95,"geoPoint":104},"The George Washington University","Washington D.C.","District of Columbia","20052",{"lat":105,"lon":106},38.89511,-77.03637,{"facility":108,"city":109,"state":110,"country":111,"geoPoint":112},"University of Alberta","Edmonton","Alberta","Canada",{"lat":113,"lon":114},53.55014,-113.46871,{"facility":13,"city":116,"state":117,"zip":118,"country":111,"geoPoint":119},"Vancouver","British Columbia","V6Z 1Y6",{"lat":120,"lon":121},49.24966,-123.11934,{"facility":123,"city":124,"state":125,"zip":126,"country":111,"geoPoint":127},"Dalhousie University","Halifax","Nova Scotia","B3H 1V8",{"lat":128,"lon":129},44.64269,-63.57688,{"facility":131,"city":132,"state":133,"zip":134,"country":111,"geoPoint":135},"St. Joseph's Healthcare","Hamilton","Ontario","L8N 4A6",{"lat":136,"lon":137},43.25011,-79.84963,{"facility":139,"city":140,"state":133,"country":111,"geoPoint":141},"Kingston Health Science Centre","Kingston",{"lat":142,"lon":143},44.22976,-76.48098,{"facility":145,"city":146,"state":133,"country":111,"geoPoint":147},"London Health Science Centre","London",{"lat":148,"lon":149},42.98339,-81.23304,{"facility":151,"city":152,"state":133,"zip":153,"country":111,"geoPoint":154},"The Ottawa Hospital Research Institute","Ottawa","K1H 7W9",{"lat":155,"lon":156},45.41117,-75.69812,{"facility":158,"city":159,"state":133,"zip":160,"country":111,"geoPoint":161},"University Health Network","Toronto","M5G 2N2",{"lat":162,"lon":163},43.70643,-79.39864,{"facility":165,"city":159,"state":133,"country":111,"geoPoint":166},"St Michael's Hospital",{"lat":162,"lon":163},{"facility":168,"city":169,"state":170,"country":111,"geoPoint":171},"CHU de Quebec-Universite Laval's L'Hotel-Dieu de Quebec","Laval","Quebec",{"lat":172,"lon":173},45.56995,-73.692,{"facility":175,"city":176,"state":170,"zip":177,"country":111,"geoPoint":178},"University of Montreal, Maisonneuve-Rosemont Hospital","Montreal","H1T 2M4",{"lat":179,"lon":180},45.50884,-73.58781,{"facility":182,"city":176,"state":170,"country":111,"geoPoint":183},"McGill University Health Centre",{"lat":179,"lon":180},{"facility":185,"city":176,"state":170,"country":111,"geoPoint":186},"Universite de Montreal, Hopital Maisonneuve-Rosemont",{"lat":179,"lon":180},{"facility":188,"city":189,"state":190,"country":111,"geoPoint":191},"St. Paul's Hospital, University of Saskatchewan","Saskatoon","Saskatchewan",{"lat":192,"lon":193},52.13238,-106.66892,{"facility":195,"city":196,"country":197,"geoPoint":198},"Charité Universitätsmedizin","Berlin","Germany",{"lat":199,"lon":200},52.52437,13.41053,{"facility":202,"city":203,"zip":204,"country":205,"geoPoint":206},"Sussex Brighton R&D","Brighton","BN2 1ES","United Kingdom",{"lat":207,"lon":208},50.82838,-0.13947,{"facility":210,"city":211,"zip":212,"country":205,"geoPoint":213},"King's College Hospital NHS Foundation Trust","Brixton","SW9 8RR",{"lat":214,"lon":215},51.46593,-0.10652,{"facility":217,"city":218,"zip":219,"country":205,"geoPoint":220},"Epsom and St Helier University Hospitals NHS Trust","Carshalton","SM5 1AA",{"lat":221,"lon":222},51.36829,-0.16755,{"facility":224,"city":146,"zip":225,"country":205,"geoPoint":226},"Barts Health NHS Trust","E1 4UJ",{"lat":227,"lon":228},51.50853,-0.12574,{"facility":230,"city":146,"country":205,"geoPoint":231},"St George's University Hospital NHS Trust Foundation",{"lat":227,"lon":228},[],[234],{"name":235,"affiliation":13,"role":236},"Jagbir Gill, MD","PRINCIPAL_INVESTIGATOR",[238],{"pmid":239,"type":240,"citation":241},"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\u002Fj.ahj.2019.05.008. Epub 2019 May 22.",[],{"nct_id":4,"conditions":244,"biomarkers":246},[245,21],"Chronic Kidney Disease, Stage 5",[],{"nct_id":4,"found":15,"summary":248,"prompt_version":258},{"design":249,"status":250,"heading":251,"summary":252,"follow_up":253,"word_count":254,"commitments":255,"compensation":256,"drugs_mentioned":257},"This is an interventional study comparing two groups: one with regular screening for heart disease and one with no further screening. It plans to include 3306 participants.","completed","Screening for Heart Disease in Kidney Transplant Candidates","This study, called CARSK, is looking at how we screen for heart disease (coronary artery disease or CAD) in people waiting for a kidney transplant. Currently, people are screened every 1-2 years. This study wants to see if stopping this regular screening after you're on the waitlist is just as safe as continuing it. The study will compare two groups: one that continues regular screening and one that doesn't have further screening after joining the waitlist. The main goal is to see if one approach leads to fewer serious heart problems (Major Adverse Cardiac Events or MACE). You might be able to join if you are an adult, have kidney failure requiring dialysis, are being assessed for or are on the kidney transplant waiting list, and are expected to need CAD screening before transplant. The study aims to enroll 3306 participants, but its current recruitment status is unclear.","Participants will be followed for up to 60 months, with a maximum follow-up of 72 months, including 12 months after transplant.",148,"Not specified in the trial record.","Not stated in the trial record.",[37],"v2"]