About this trial
Cardiovascular disease (for example, heart attack, stroke, heart failure) is the commonest complication of kidney failure. Kidney transplantation reduces cardiovascular risk but cardiovascular disease remains the commonest cause of death in patients following transplantation.
Current strategies to assess patient's cardiovascular risk prior to kidney transplantation do not identify those at highest risk and do not improve outcomes.
This study will use a heart scan known as computed tomography coronary angiography (CTCA) to see whether this scan can identify patients at highest risk of future cardiovascular disease prior to transplantation. Studies have shown it is able to do this in patients with normal kidney function.
The aim of this study is to develop CTCA as an effective tool to risk stratify patients prior to kidney transplantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has kidney failure and is on the waitlist for a kidney transplant
Age 16 years and over
Able to give informed consent
Disqualifiers
Contraindication to CT scanning, including contrast allergy
Patients being considered for a simultaneous kidney-pancreas, kidney-liver and/or kidney-islet transplantation
Inability to give informed consent
Trial population
Patients on the kidney transplant waitlist
Trial design
Cohort
Prospective
Treatments tested in this trial
Computed tomography coronary angiography (CTCA)
RadiationSingle CTCA scan prior to kidney transplantation
Treatment groups
Trial outcomes
Primary outcomes
Number of participants who have either a myocardial infarction or cardiovascular death
The first event of myocardial infarction or cardiovascular death
Secondary outcomes
Number of participants who have a fatal or non-fatal myocardial infarction
The first event of myocardial infarction (MI). MI will be defined according to the 4th Universal Definition of Myocardial Infarction.
Number of participants who are hospitalised due to any cardiovascular event
Hospital admission due to any cardiovascular event (including myocardial infarction, heart failure, stroke, or any other cardiovascular disease)
Number of participants who die (all-cause death)
Death due to any cause
Number of participants who have a cardiovascular death
Death due to a cardiovascular cause (including myocardial infarction, heart failure, stroke, or any other cardiovascular disease)
Other outcomes
Number of participants who suffer a clinically significant acute kidney injury following study CTCA scan
Unexpected progression to dialysis (haemodialysis or peritoneal dialysis) within 28 days of study CTCA scan
Number of participants who have clinically significant abnormal non-cardiac findings on study CTCA scan
Abnormal non-cardiac findings (e.g., lung mass), not related to a pre-existing condition and requiring further investigation
Sponsors and contacts
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University of Edinburgh
Lead sponsor
Chief Scientist Office of the Scottish Government
Collaborator
University of Glasgow
Collaborator
NHS Lothian
Collaborator
NHS Greater Glasgow and Clyde
Collaborator