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

NCT06234410 | Recruiting

• 1 other identifier: TCS/22/09
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Transplant; Complications; Cardiovascular Diseases

Keywords

Coronary artery disease; Kidney transplantation; Cardiovascular risk assessment; Heart disease; Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

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

  The first event of myocardial infarction or cardiovascular death

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

Secondary Outcomes (4)

• Number of participants who have a fatal or non-fatal myocardial infarction

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

• Number of participants who are hospitalised due to any cardiovascular event

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

• Number of participants who die (all-cause death)

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

• Number of participants who have a cardiovascular death

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

Other Outcomes (2)

• Number of participants who suffer a clinically significant acute kidney injury following study CTCA scan

  From time of CTCA scan to 28 days follow-up

• Number of participants who have clinically significant abnormal non-cardiac findings on study CTCA scan

  From time of CTCA scan to 12 months follow-up

Study Arms (1)

Patients waitlisted for kidney transplantation

Patients who have been placed on the waiting list for a kidney transplant within Scotland

Radiation: Computed tomography coronary angiography (CTCA)

Interventions

Computed tomography coronary angiography (CTCA) RADIATION

Single CTCA scan prior to kidney transplantation

Patients waitlisted for kidney transplantation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients on the kidney transplant waitlist

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chief Scientist Office of the Scottish Government: collaborator
• NHS Lothian: collaborator
• NHS Greater Glasgow and Clyde: collaborator
• University of Edinburgh: lead
• University of Glasgow: collaborator

Study Sites (2)

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

RECRUITING

Queen Elizabeth Hospital

Glasgow, G51 4TF, United Kingdom

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma (including for potential genetic analysis) will be taken from participants and stored.

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Heart Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neeraj Dhaun, MBChB

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gavin B Chapman, MBChB

CONTACT

00447713349318; gchapma2@ed.ac.uk

Neeraj Dhaun, MBChB

CONTACT

bean.dhaun@ed.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: January 24, 2024
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): January 1, 2032
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

GB (2)