Canadian-Australasian Randomised Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,306
- 试验地点
- 34
- 主要终点
- MACE
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
No screening
No further screening for asymptomatic coronary artery disease after wait-list entry
干预措施: No screening (Other)
Regular screening
Regular (yearly or 2nd yearly) screening for asymptomatic coronary artery disease after wait-list entry
干预措施: Regular Screening (Other)
结局指标
主要结局
MACE
时间窗: 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: 1. Notification to the transplant coordinators when patients are admitted in hospital (this is the usual standard of care in waitlisted patients). 2. 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. 3. Patients will be followed up 6-monthly (alternating by phone and clinic visits) where trial coordinators will discuss any hospitalisation with the patients.
次要结局
- Stroke(Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant)
- Time of wait-listing(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(Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant)
- Emergency revascularisation(Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant)
- Incidence of transplantation(Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant)
- All-cause death(Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant)
- Health related quality of life(Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant)
- Cost effectiveness(The analysis will take place at the end of the study. This outcome will be followed up for 5 years.)
- 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(Between 24 and 72 months, depending on patient's date of transplant. Follow-up will be 12 months posttransplant)
研究者
John Gill
Professor of Medicine
University of British Columbia