Screening Strategies for Coronary Artery Disease in Kidney Transplant Candidates

(CARSK Trial)

Recruiting at 25 trial locations

Overseen By Gurvir Thind

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Uncontrolled cardiac disease, Other transplants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

3306 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether skipping regular heart screenings for kidney transplant candidates is as safe as conducting them annually. It focuses on individuals with kidney failure who are on dialysis and on the transplant waiting list. Participants will either continue with routine heart check-ups (regular screening) or have no additional screenings unless symptoms appear (no screening). The main goal is to determine if less frequent screenings prevent serious heart problems just as effectively and to assess the impact on transplant rates and costs. This trial suits those with stable heart health who are expected to wait more than a year for a kidney transplant. As an unphased trial, it offers a unique opportunity to contribute to research that could simplify care and reduce costs for future transplant patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that regular heart disease screening for individuals awaiting a kidney transplant might not be as safe as it appears. Studies have found that this practice can lead to more complications, particularly after revascularizations, which are procedures to open blocked arteries. Some evidence suggests that screening might increase health risks and could delay or prevent patients from receiving a transplant.

Furthermore, regular screening has not been proven to improve health outcomes for these patients. The screening itself might cause unnecessary stress and harm, rather than preventing major heart issues. Given these concerns, potential trial participants should carefully consider the risks and benefits of regular heart disease screening. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different screening strategies for coronary artery disease in kidney transplant candidates. Unlike traditional care, which may not include consistent monitoring for asymptomatic coronary artery disease, this trial compares no further screening against regular, scheduled screenings. This approach could help identify heart issues early, potentially improving patient outcomes and transplant success. By discovering the most effective screening method, the trial aims to enhance the safety and longevity of kidney transplant recipients.

What evidence suggests that this trial's screening strategies could be effective for coronary artery disease in kidney transplant candidates?

This trial will compare two strategies for screening coronary artery disease in kidney transplant candidates: no screening and regular screening. Research has shown that regularly checking for heart disease in people waiting for a kidney transplant doesn't seem to help. Studies suggest that looking for hidden heart problems (when there are no symptoms) doesn't predict heart issues in these patients. Specifically, one study found that more people who didn't have regular heart checks received a transplant after five years compared to those who did. Overall, little evidence supports that routine heart checks improve transplant success or reduce heart problems in this group. ^{2 5 6 7 8}

Who Is on the Research Team?

Jagbir Gill, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

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 may need to be checked for heart disease before getting a transplant, as per usual medical practice.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• No screening
• Regular Screening

Trial Overview 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.

How Is the Trial Designed?

Group I: No screening Experimental Treatment 1 Intervention

No further screening for asymptomatic coronary artery disease after wait-list entry

Group II: Regular screening Active Control 1 Intervention

Regular (yearly or 2nd yearly) screening for asymptomatic coronary artery disease after wait-list entry

Regular Screening is already approved in Canada 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

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

University of Sydney

Collaborator

Trials

208

Recruited

417,000+

Published Research Related to This Trial

In a study of 360 patients on the kidney transplant waitlist, the 6-minute walk test (6MWT) identified about 45% as 'low risk' for coronary artery disease (CAD), compared to only 14% and 81% using traditional risk factor or symptom-based methods, respectively.

While the 6MWT did not significantly predict CAD-related events within one year, it was associated with competing events, suggesting it may be more useful for assessing overall health and fitness rather than solely for CAD risk stratification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance versus Risk Factor-Based Approaches to Coronary Artery Disease Screening in Waitlisted Kidney Transplant Candidates. Cheng, XS., Watford, DJ., Arashi, H., et al.[2022]

Dobutamine stress echocardiography (DSE) and myocardial perfusion scintigraphy (MPS) are moderately effective non-invasive tests for detecting coronary artery disease (CAD) in kidney transplant candidates, with DSE showing slightly better accuracy than MPS.

The study analyzed data from multiple trials, revealing that while DSE had a pooled sensitivity of 79% and specificity of 89%, MPS had a sensitivity of 74% and specificity of 70%, indicating that both tests can help identify patients at risk for CAD before transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac testing for coronary artery disease in potential kidney transplant recipients. Wang, LW., Fahim, MA., Hayen, A., et al.[2021]

Screening for coronary artery disease (CAD) is crucial before kidney transplant surgery due to the high risk of cardiovascular issues in chronic kidney disease patients, especially those with diabetes or a history of heart problems.

Cardiac stress testing is often unreliable for detecting CAD in kidney transplant candidates, so coronary angiography is recommended for high-risk patients to ensure better assessment and safety before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Cardiac Evaluation in Kidney Transplant Patients: Is Coronary Angiography Superior? A Focused Review. Katta, N., Balla, S., Velagapudi, P., et al.[2017]

In a study of 1053 adult patients evaluated for kidney transplantation, non-invasive cardiac stress studies (NISS) identified treatable coronary disease but only influenced clinical management in 2% of cases, indicating limited overall benefit.

Patients with abnormal NISS had longer wait times for listing (9.9 months) compared to those with normal NISS (6.9 months), suggesting that while NISS can identify issues, it may also lead to significant delays in the transplant process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive cardiac stress studies may not offer significant benefit in pre-kidney transplant evaluation: A retrospective cohort study. Kanigicherla, DAK., Bhogal, T., Stocking, K., et al.[2020]

In a study of 79,334 first-time kidney transplant recipients, pretransplant coronary heart disease (CHD) testing did not lead to a reduction in early posttransplant death or myocardial infarction (MI), suggesting that routine testing may not be necessary.

Interestingly, during the earliest study period (2000-2003), CHD testing was associated with a higher event rate of complications, indicating that the practice of pretransplant testing may need to be reevaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Pretransplant Coronary Heart Disease Testing With Early Kidney Transplant Outcomes. Cheng, XS., Liu, S., Han, J., et al.[2023]

In a study of 126 renal transplant candidates, coronary angiography revealed a 42% prevalence of significant coronary artery disease (CAD), highlighting the need for accurate detection methods in this population.

Noninvasive tests like myocardial scintigraphy and dobutamine stress echocardiography had sensitivities and negative predictive values below 75%, suggesting that these methods may not be reliable for assessing cardiac risk, and that coronary angiography remains essential for accurate diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary angiography is the best predictor of events in renal transplant candidates compared with noninvasive testing. De Lima, JJ., Sabbaga, E., Vieira, ML., et al.[2022]

Out of 94,832 kidney transplant recipients studied from 2000 to 2015, 39% underwent at least one nonurgent coronary artery disease (CAD) test in the year before their transplant, with testing rates remaining stable despite changes in cardiology guidelines.

The rate of death or nonfatal myocardial infarction within 30 days after transplant decreased from 3% in 2000 to 2% in 2015, indicating improved short-term outcomes for kidney transplant recipients over the years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in Coronary Artery Disease Screening before Kidney Transplantation. Cheng, XS., Liu, S., Han, J., et al.[2023]

In a study of 2572 kidney transplant recipients, pre-transplant screening for asymptomatic coronary artery disease using stress tests or coronary angiograms did not significantly reduce major adverse cardiac events (MACE) up to five years post-transplant.

The analysis of 1760 matched individuals revealed no statistically significant difference in MACE rates between those who underwent screening and those who did not, suggesting that routine screening practices may need to be reconsidered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A propensity score-matched analysis indicates screening for asymptomatic coronary artery disease does not predict cardiac events in kidney transplant recipients. Nimmo, A., Forsyth, JL., Oniscu, GC., et al.[2021]

The CARSK study will evaluate whether eliminating routine screening for coronary artery disease (CAD) in kidney transplant candidates is as safe as regular screening, potentially avoiding unnecessary delays and complications for patients awaiting transplantation.

With a goal to enroll 3,306 patients over 3 years and follow them for up to 5 years, the study aims to assess not only the safety and efficacy of screening but also its impact on transplant rates and healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canadian-Australasian Randomised trial of screening kidney transplant candidates for coronary artery disease-A trial protocol for the CARSK study. Ying, T., Gill, J., Webster, A., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10453389/

Screening and Management of Coronary Artery Disease in ... This review summarizes the key points of cardiovascular risk assessment in renal transplant candidates and faces the role of noninvasive ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001104

Emerging Evidence on Coronary Heart Disease Screening ... Coronary heart disease screening in asymptomatic kidney and liver transplantation candidates has not been demonstrated to improve outcomes but ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03674307

Screening for Asymptomatic Coronary Artery Disease in ... Secondary analyses will assess the impact of screening on the rate of transplantation, and the relative cost-effectiveness of screening. Detailed Description.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S027263861931056X

Screening for Asymptomatic Coronary Artery Disease in ... A propensity score–matched analysis indicates screening for asymptomatic coronary artery disease does not predict cardiac events in kidney transplant recipients.

5. ajkd.org ajkd.org/article/S0272-6386(19)31159-X/fulltext

The Cost of Screening Kidney Transplant Candidates for ... In addition, a higher proportion of patients in the no-further-screening arm received a transplant after 5 years compared with the regular ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31228771/

Canadian-Australasian Randomised trial of screening ... Screening is potentially harmful because patients may be excluded or delayed from transplantation, and complications after revascularization are more frequent ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02082483

Coronary Artery Disease Screening in Kidney Transplant ... Currently patients undergo annual testing; however, screening for CAD may increase morbidity and mortality by:

8. kdigo.org kdigo.org/wp-content/uploads/2017/05/KDIGO_Webster_Vienna_wm.pdf

in kidney transplant candidates • Testing for coronary artery disease in kidney transplant candidates. • Relative diagnostic performance of non-invasive tests. • Relative prognostic ...