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

Recruiting

• Conditions: Cardiovascular Diseases; Kidney Transplant; Complications
• Interventions: Radiation: Computed tomography coronary angiography (CTCA)

• Registration Number: NCT06234410
• Lead Sponsor: University of Edinburgh

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study Start: 2024-01-24
• Study First Posted: 2024-01-31
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2032-01
• Study Completion: 2032-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients waitlisted for kidney transplantation	Computed tomography coronary angiography (CTCA)	Patients who have been placed on the waiting list for a kidney transplant within Scotland

Primary Outcome Measures

Name	Time	Method
Number of participants who have either a myocardial infarction or cardiovascular death	From time of CTCA scan to 36- and 60-months follow-up	The first event of myocardial infarction or cardiovascular death

Secondary Outcome Measures

Name	Time	Method
Number of participants who are hospitalised due to any cardiovascular event	From time of CTCA scan to 36- and 60-months follow-up	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)	From time of CTCA scan to 36- and 60-months follow-up	Death due to any cause
Number of participants who have a cardiovascular death	From time of CTCA scan to 36- and 60-months follow-up	Death due to a cardiovascular cause (including myocardial infarction, heart failure, stroke, or any other cardiovascular disease)
Number of participants who have a fatal or non-fatal myocardial infarction	From time of CTCA scan to 36- and 60-months follow-up	The first event of myocardial infarction (MI). MI will be defined according to the 4th Universal Definition of Myocardial Infarction.

Trial Locations

Locations (2)

Queen Elizabeth Hospital; 🇬🇧 Glasgow, United Kingdom

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Lothian, United Kingdom