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

February 5, 2024 updated by: University of Edinburgh

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

332

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Not yet recruiting
        • Queen Elizabeth Hospital
        • Contact:
        • Principal Investigator:
          • Patrick Mark, MBChB
        • Sub-Investigator:
          • Rajan Patel, MBChB
        • Sub-Investigator:
          • Gavin Chapman, MBChB
        • Sub-Investigator:
          • Giles Roditi, MBChB
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH16 4SA
        • Recruiting
        • Royal Infirmary of Edinburgh
        • Contact:
        • Sub-Investigator:
          • Gavin B Chapman, MBChB
        • Principal Investigator:
          • Neeraj Dhaun, MBChB
        • Sub-Investigator:
          • Nicholas Mills, MBChB
        • Sub-Investigator:
          • Michelle Williams, MBChB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients on the kidney transplant waitlist

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Single CTCA scan prior to kidney transplantation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who have a fatal or non-fatal myocardial infarction
Time Frame: 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.
From time of CTCA scan to 36- and 60-months follow-up
Number of participants who are hospitalised due to any cardiovascular event
Time Frame: 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)
From time of CTCA scan to 36- and 60-months follow-up
Number of participants who die (all-cause death)
Time Frame: From time of CTCA scan to 36- and 60-months follow-up
Death due to any cause
From time of CTCA scan to 36- and 60-months follow-up
Number of participants who have a cardiovascular death
Time Frame: 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)
From time of CTCA scan to 36- and 60-months follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who suffer a clinically significant acute kidney injury following study CTCA scan
Time Frame: From time of CTCA scan to 28 days follow-up
Unexpected progression to dialysis (haemodialysis or peritoneal dialysis) within 28 days of 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
Time Frame: From time of CTCA scan to 12 months follow-up
Abnormal non-cardiac findings (e.g., lung mass), not related to a pre-existing condition and requiring further investigation
From time of CTCA scan to 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian
NHS Greater Glasgow and Clyde
University of Glasgow
Chief Scientist Office of the Scottish Government

Investigators

  • Principal Investigator: Neeraj Dhaun, MBChB, University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2024

Primary Completion (Estimated)

January 1, 2032

Study Completion (Estimated)

January 1, 2032

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCS/22/09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Following publication of the primary paper, a deidentified individual participant data set will be will be made available for data sharing purposes, subject to necessary governance approvals. Access to the deidentified dataset will be under a controlled access model.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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