Clinical trial NCT06234410: Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Official title: Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Kidney Transplant; Complications
Keywords: Coronary artery disease
Kidney transplantation
Cardiovascular risk assessment
Heart disease
Chronic kidney disease
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Chief Scientist Office of the Scottish Government
name: University of Glasgow
name: NHS Lothian
name: NHS Greater Glasgow and Clyde
First posted: 2024-01-31
Enrollment: 332
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on the kidney transplant waitlist

Brief summary: 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: Inclusion Criteria:

* Has kidney failure and is on the waitlist for a kidney transplant
* Age 16 years and over
* Able to give informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants who have either a myocardial infarction or cardiovascular death
timeFrame: From time of CTCA scan to 36- and 60-months follow-up
Secondary outcomes:
measure: Number of participants who have a fatal or non-fatal myocardial infarction
timeFrame: From time of CTCA scan to 36- and 60-months follow-up
measure: Number of participants who are hospitalised due to any cardiovascular event
timeFrame: From time of CTCA scan to 36- and 60-months follow-up
measure: Number of participants who die (all-cause death)
timeFrame: From time of CTCA scan to 36- and 60-months follow-up
measure: Number of participants who have a cardiovascular death
timeFrame: From time of CTCA scan to 36- and 60-months follow-up
Other outcomes:
measure: Number of participants who suffer a clinically significant acute kidney injury following study CTCA scan
timeFrame: From time of CTCA scan to 28 days follow-up
measure: Number of participants who have clinically significant abnormal non-cardiac findings on study CTCA scan
timeFrame: From time of CTCA scan to 12 months follow-up
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Lothian
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth Hospital
Study officials:
affiliation: University of Edinburgh
name: Neeraj Dhaun, MBChB
role: PRINCIPAL_INVESTIGATOR
References: