Screening Strategies for Coronary Artery Disease in Kidney Transplant Candidates
(CARSK Trial)
Recruiting in Palo Alto (17 mi)
+21 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of British Columbia
Disqualifiers: Uncontrolled cardiac disease, Other transplants, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment strategies for coronary artery disease screening in kidney transplant candidates?
Research suggests that while non-invasive screening tests are commonly used to identify coronary artery disease in kidney transplant candidates, their effectiveness in improving outcomes is not well-established. Some studies indicate that eliminating these screenings may not lead to worse outcomes, suggesting that regular non-invasive screening might not be necessary for all patients.
12345Is screening for coronary artery disease safe for kidney transplant candidates?
Screening for coronary artery disease in kidney transplant candidates is generally considered safe, but it may lead to delays or exclusion from transplantation and has potential complications, especially after revascularization (restoring blood flow to the heart).
13467How is the Regular Screening treatment for coronary artery disease in kidney transplant candidates different from other treatments?
Regular Screening for coronary artery disease in kidney transplant candidates is unique because it focuses on non-invasive tests to identify high-risk patients, unlike more invasive procedures like coronary angiography. This approach is particularly important for kidney transplant candidates who may have asymptomatic coronary artery disease, making early detection crucial.
12389Eligibility Criteria
This trial is for adults over 18 with dialysis-dependent kidney failure who are being assessed for or on the waiting list for a kidney transplant. They must need further heart disease screening and expect to undergo transplantation more than a year after joining the study. Those with other organ transplants, uncontrolled cardiac issues, or unable to consent are excluded.Inclusion Criteria
You need dialysis for kidney failure or are waiting for a kidney transplant.
Able to give consent
You are 18 years old or older.
+2 more
Exclusion Criteria
You have had a transplant of a different organ.
You are scheduled to receive an organ from a living donor.
Patients unable to give consent
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Regular Screening
Regular (yearly or 2nd yearly) screening for asymptomatic coronary artery disease after wait-list entry
24-72 months
Annual or biennial visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months post-transplant
6-monthly visits (alternating by phone and clinic)
No Screening
No further screening for asymptomatic coronary artery disease after wait-list entry
24-72 months
Participant Groups
The CARSK trial is examining if not regularly using non-invasive tests to check for coronary artery disease in kidney transplant candidates is as effective as annual screenings in preventing major heart problems. It also looks at how screening affects transplant rates and its cost-effectiveness.
2Treatment groups
Experimental Treatment
Active Control
Group I: No screeningExperimental Treatment1 Intervention
No further screening for asymptomatic coronary artery disease after wait-list entry
Group II: Regular screeningActive Control1 Intervention
Regular (yearly or 2nd yearly) screening for asymptomatic coronary artery disease after wait-list entry
Regular Screening is already approved in Canada, Australia for the following indications:
🇨🇦 Approved in Canada as Regular Screening for Coronary Artery Disease for:
- Prevention of Major Adverse Cardiac Events in Kidney Transplant Candidates
🇦🇺 Approved in Australia as Regular Screening for Coronary Artery Disease for:
- Prevention of Major Adverse Cardiac Events in Kidney Transplant Candidates
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
St. Paul's Hospital, University of SaskatchewanSaskatoon, Canada
Universite de Montreal, Hopital Maisonneuve-RosemontMontréal, Canada
Dalhousie UniversityHalifax, Canada
University Health NetworkToronto, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
University of SydneyCollaborator
References
Cardiac testing for coronary artery disease in potential kidney transplant recipients. [2021]Patients with chronic kidney disease (CKD) are at increased risk of coronary artery disease (CAD) and adverse cardiac events. Screening for CAD is therefore an important part of preoperative evaluation for kidney transplant candidates. There is significant interest in the role of non-invasive cardiac investigations and their ability to identify patients at high risk of CAD.
Performance versus Risk Factor-Based Approaches to Coronary Artery Disease Screening in Waitlisted Kidney Transplant Candidates. [2022]Current screening algorithms for coronary artery disease (CAD) before kidney transplantation result in many tests but few interventions.
Non-invasive cardiac stress studies may not offer significant benefit in pre-kidney transplant evaluation: A retrospective cohort study. [2020]Screening with cardiac non-invasive stress studies (NISS) prior to listing for kidney transplantation can help in identifying treatable coronary disease and is considered an integral part of pre-kidney transplant evaluation. However, few studies assessed their effectiveness in all patients evaluated for transplantation in clinical practice. To evaluate the role of NISS in pre-kidney transplant evaluation we analyzed their impact prior to waitlisting in 1053 adult CKD-5 patients consecutively evaluated in Greater Manchester, UK during a 6-year period.
Canadian-Australasian Randomised trial of screening kidney transplant candidates for coronary artery disease-A trial protocol for the CARSK study. [2020]Transplantation is the preferred treatment for patients with kidney failure, but the need exceeds the supply of transplantable kidneys, and patients routinely wait >5 years on dialysis for a transplant. Coronary artery disease (CAD) is common in kidney failure and can exclude patients from transplantation or result in death before or after transplantation. Screening asymptomatic patients for CAD using noninvasive tests prior to wait-listing and at regular intervals (ie, annually) after wait-listing until transplantation is the established standard of care and is justified by the need to avoid adverse patient outcomes and loss of organs. Patients with abnormal screening tests undergo coronary angiography, and those with critical stenoses are revascularized. Screening is potentially harmful because patients may be excluded or delayed from transplantation, and complications after revascularization are more frequent in this population. CARSK will test the hypothesis that eliminating screening tests for occult CAD after wait-listing is not inferior to regular screening for the prevention of major adverse cardiac events defined as the composite of cardiovascular death, nonfatal myocardial infarction, urgent revascularization, and hospitalization for unstable angina. Secondary outcomes include the transplant rate, safety measures, and the cost-effectiveness of screening. Enrolment of 3,306 patients over 3 years is required, with patients followed for up to 5 years during wait-listing and for 1 year after transplantation. By validating or refuting the use of screening tests during wait-listing, CARSK will ensure judicious use of health resources and optimal patient outcomes.
Coronary angiography is the best predictor of events in renal transplant candidates compared with noninvasive testing. [2022]Guidelines for the detection of coronary artery disease (CAD) and assess of risk in renal transplant candidates are based on the results of noninvasive testing, according to data originated in the nonuremic population. We evaluated prospectively the accuracy of 2 noninvasive tests and risk stratification in detecting CAD (>or=70% obstruction) and assessing cardiac risk by using coronary angiography (CA). One hundred twenty-six renal transplant candidates who were classified as at moderate (>or=50 years) or high (diabetes, extracardiac atherosclerosis, or clinical coronary artery disease) coronary risk underwent myocardial scintigraphy (SPECT), dobutamine stress echocardiography, and CA and were followed for 6 to 48 months. The prevalence of CAD was 42%. The sensitivities and negative predictive values for the 2 noninvasive tests and risk stratification were or=70% stenosis. Multivariate analysis showed that the sole predictor of cardiac events was critical coronary lesions (P=0.003). Coronary angiography may still be necessary for detecting CAD and determining cardiac risk in renal transplant candidates. The data suggest that current algorithms based on noninvasive testing in this population should be revised.
A propensity score-matched analysis indicates screening for asymptomatic coronary artery disease does not predict cardiac events in kidney transplant recipients. [2021]Screening for asymptomatic coronary artery disease prior to kidney transplantation aims to reduce peri- and post-operative cardiac events. It is uncertain if this is achieved. Here, we investigated whether pre-transplant screening with a stress test or coronary angiogram associated with any difference in major adverse cardiac events (MACE) up to five years post-transplantation. We examined a national prospective cohort recruited to the Access to Transplant and Transplant Outcome Measures study who received a kidney transplant between 2011-2017, and linked patient demographics and details of cardiac screening investigations to outcome data extracted from the Hospital Episode Statistics dataset and United Kingdom Renal Registry. Propensity score matched groups were analyzed using Kaplan-Meier and Cox survival analyses. Overall, 2572 individuals were transplanted in 18 centers; 51% underwent screening and the proportion undergoing screening by center ranged from 5-100%. The incidence of MACE at 90 days, one and five years was 0.9%, 2.1% and 9.4% respectively. After propensity score matching based on the presence or absence of screening, 1760 individuals were examined (880 each in screened and unscreened groups). There was no statistically significant association between screening and MACE at 90 days (hazard ratio 0.80, 95% Confidence Interval 0.31-2.05), one year (1.12, 0.51-2.47) or five years (1.31, 0.86-1.99). Age, male sex and history of ischemic heart disease were associated with MACE. Thus, there is no association between screening for asymptomatic coronary artery disease and MACE up to five years post-transplant. Practices involving unselected screening of transplant recipients should be reviewed.
Association of Pretransplant Coronary Heart Disease Testing With Early Kidney Transplant Outcomes. [2023]Testing for coronary heart disease (CHD) in asymptomatic kidney transplant candidates before transplant is widespread and endorsed by various professional societies, but its association with perioperative outcomes is unclear.
Preoperative Cardiac Evaluation in Kidney Transplant Patients: Is Coronary Angiography Superior? A Focused Review. [2017]Cardiovascular disease is the major cause of morbidity and mortality in chronic kidney disease patients. Because of a higher occurrence of asymptomatic coronary artery disease and increased perioperative cardiovascular mortality in kidney transplant patients, screening for coronary artery disease before transplant surgery is essential. Various studies have shown that cardiac stress testing is an unreliable screening method in these patients because of significant variability in sensitivity and negative predictive value. We suggest that high-risk candidates such as those with diabetes or a prior history of myocardial infarction, stroke, peripheral vascular disease, or coronary artery disease should perhaps be considered for coronary angiography rather than stress testing as cardiac screening before kidney transplantation.
Trends in Coronary Artery Disease Screening before Kidney Transplantation. [2023]Coronary artery disease (CAD) screening in asymptomatic kidney transplant candidates is widespread but not well supported by contemporary cardiology literature. In this study we describe temporal trends in CAD screening before kidney transplant in the United States.