Screening Strategies for Coronary Artery Disease in Kidney Transplant Candidates

(CARSK Trial)

Recruiting at 21 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

Trial Summary

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. ^{1 2 3 4 5}

Is 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). ^{1 3 4 6 7}

How 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. ^{1 2 3 8 9}

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.

Research Team

Jagbir Gill, MD

Principal Investigator

University of British Columbia

Eligibility 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 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Cardiac testing for coronary artery disease in potential kidney transplant recipients. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Performance versus Risk Factor-Based Approaches to Coronary Artery Disease Screening in Waitlisted Kidney Transplant Candidates. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Non-invasive cardiac stress studies may not offer significant benefit in pre-kidney transplant evaluation: A retrospective cohort study. [2020]

4. United States 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Coronary angiography is the best predictor of events in renal transplant candidates compared with noninvasive testing. [2022]

6. United States 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Association of Pretransplant Coronary Heart Disease Testing With Early Kidney Transplant Outcomes. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Preoperative Cardiac Evaluation in Kidney Transplant Patients: Is Coronary Angiography Superior? A Focused Review. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Trends in Coronary Artery Disease Screening before Kidney Transplantation. [2023]