Cardiovascular DiseasesCRAFT-CTCANCT06234410
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
An observational study of Cardiovascular Diseases and Kidney Transplant; Complications, run by University of Edinburgh at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cardiovascular Diseases, Kidney Transplant; Complications
- What is being tested?
- Computed tomography coronary angiography (CTCA)
- Type of treatment
- Surgery or procedure
- How many people
- 332 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 24 Jan 2024to Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients on the kidney transplant waitlist
Who may be able to join
- Has kidney failure and is on the waitlist for a kidney transplant
- Age 16 years and over
- Able to give informed consent
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Neeraj Dhaun, MBChB contact
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA
Gavin B Chapman, MBChB, 00447713349318, gchapma2@ed.ac.uk
Gavin B Chapman, MBChB
- Recruiting
Queen Elizabeth Hospital
Glasgow, G51 4TF
Rajan Patel, MBChB, Rajan.Patel2@nhs.scot
Patrick Mark, MBChB
- Recruiting
Imperial College Healthcare NHS Trust
London
Christopher Baker, +442033131928, christopher.baker1@nhs.net
Christopher Baker
- Recruiting
University Hospitals Plymouth NHS Trust
Plymouth
Kris Houlberg, +441752432842, kris.houlberg@nhs.net
Kris Houlberg
- Recruiting
Sheffield Teaching Hospitals NHS Trust
Sheffield
William McKane, +441142266466, william.mckane@nhs.net
William McKane
About this study
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.
Read more
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.
- Being tested
- Computed tomography coronary angiography (CTCA)
- Keywords
- Coronary artery disease, Kidney transplantation, Cardiovascular risk assessment, Heart disease, Chronic kidney disease
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Heart Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography coronary angiography (CTCA)Radiation
Single CTCA scan prior to kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| Patients waitlisted for kidney transplantation | Patients who have been placed on the waiting list for a kidney transplant within Scotland Receives: Radiation: Computed tomography coronary angiography (CTCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who have either a myocardial infarction or cardiovascular death
The first event of myocardial infarction or cardiovascular death
Measured: 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
The first event of myocardial infarction (MI). MI will be defined according to the 4th Universal Definition of Myocardial Infarction.
Measured: From time of CTCA scan to 36- and 60-months follow-up
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)
Measured: From time of CTCA scan to 36- and 60-months follow-up
Number of participants who die (all-cause death)
Death due to any cause
Measured: From time of CTCA scan to 36- and 60-months follow-up
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)
Measured: From time of CTCA scan to 36- and 60-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start24 Jan 2024
- Primary completionJan 2032 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government, University of Glasgow, NHS Lothian, NHS Greater Glasgow and Clyde
- Responsible party
- Sponsor
- Investigators
- Neeraj Dhaun, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234410
- Sponsor's protocol ID
- TCS/22/09
- Acronym
- CRAFT-CTCA
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
- ClinicalTrials.gov ID
- NCT06234410
- Acronym / sponsor ID
- CRAFT-CTCA / TCS/22/09
- Keywords
- Coronary artery disease, Kidney transplantation, Cardiovascular risk assessment, Heart disease, Chronic kidney disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government, University of Glasgow, NHS Lothian, NHS Greater Glasgow and Clyde
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- Jan 2032 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients waitlisted for kidney transplantation | – | Radiation: Computed tomography coronary angiography (CTCA)Patients who have been placed on the waiting list for a kidney transplant within Scotland |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients on the kidney transplant waitlist
Key inclusion criteria (3 listed)
- Has kidney failure and is on the waitlist for a kidney transplant
- Age 16 years and over
- Able to give informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomography coronary angiography (CTCA)Single CTCA scan prior to kidney transplantation | Radiation | Patients waitlisted for kidney transplantation |
Primary outcome
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
4 secondary outcomes
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
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
Number of participants who die (all-cause death)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neeraj Dhaun, MBChB contact
Neeraj Dhaun, MBChB principal investigator
University of Edinburgh
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Kidney Transplant; Complications, run by University of Edinburgh at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gavin B Chapman, MBChB (00447713349318, gchapma2@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.