Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorUniversity of Edinburgh

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Computed tomography coronary angiography (CTCA)

    Radiation

    Single CTCA scan prior to kidney transplantation

Treatment groups

332 Participants
are divided into 1 treatment group
Group A: Patients waitlisted for kidney transplantation1 intervention

Trial outcomes

Primary outcomes

1

Number of participants who have either a myocardial infarction or cardiovascular death

The first event of myocardial infarction or cardiovascular death

Time frame
From time of CTCA scan to 36- and 60-months follow-up

Secondary outcomes

1

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.

Time frame
From time of CTCA scan to 36- and 60-months follow-up
2

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)

Time frame
From time of CTCA scan to 36- and 60-months follow-up
3

Number of participants who die (all-cause death)

Death due to any cause

Time frame
From time of CTCA scan to 36- and 60-months follow-up
4

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)

Time frame
From time of CTCA scan to 36- and 60-months follow-up

Other outcomes

1

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

Time frame
From time of CTCA scan to 28 days follow-up
2

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

Time frame
From time of CTCA scan to 12 months follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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