N/A
N=144
Coronary Artery Disease Screening in Kidney Transplant Candidates
End Stage Renal Disease · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02082483 ↗Enrolled (actual)
144
Serious AEs
26.4%
Results posted
Feb 2020
Primary outcome: Primary: Number of Participants Adhering to the Expected Number of Screening Tests — 59; 71 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Selective Screening (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of British Columbia
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Adhering to the Expected Number of Screening Tests |
59; 71 | — |
| PRIMARY Enrolment Rates |
15; 16; 12; 12; 21; 21 | — |
| PRIMARY Consent Rate |
144; 67 | — |
| SECONDARY Number of Participants With Cardiac Events |
0; 0; 4; 3 | — |
Summary
Kidney transplant candidates are at very high risk for coronary artery disease (CAD). The optimal strategy to monitor and maintain the cardiac fitness of patients awaiting kidney transplantation is unknown. Currently patients undergo annual testing; however, screening for CAD may increase morbidity and mortality by:
1. exposing patients to the risk of angiography and revascularization procedures
2. delaying or excluding patients from life saving transplantation.
Before proceeding with a definitive study to determine whether screening is necessary, feasibility will be determined in this pilot study.
Eligibility Criteria
Inclusion Criteria
- age greater than 18 years
- active on the deceased donor transplant waiting list
Exclusion Criteria
- patients not expected to require further screening for CAD prior to transplantation by the current standard of care. For example, a diabetic patient recently screened for CAD and expected to be transplanted <12 months from the start of the study would not require further screening according to current guidelines and would be ineligible
- patients with signs or symptoms suggestive of active cardiac disease such as unstable coronary syndromes, de-compensated heart failure, uncontrolled arrhythmia, and severe valvular heart disease
- patient who have been put "on hold" for transplantation due to a medical problem (e.g. an infection)
- prior extra-renal transplant recipients
- multi-organ transplant candidates (e.g. kidney pancreas transplant candidates)
- patients with a planned living donor transplant
- patients unable to provide informed consent
Data sourced from ClinicalTrials.gov (NCT02082483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.