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 2 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
- 2 sitesUnited Kingdom
- Study dates
- 24 Jan 2024to Jan 2032
- Phase
- Observational
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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Neeraj Dhaun, MBChB contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA
Gavin B Chapman, MBChB, 00447713349318, gchapma2@ed.ac.uk
Gavin B Chapman, MBChB
- Not yet recruiting
Queen Elizabeth Hospital
Glasgow, G51 4TF
Patrick Mark, MBChB, patrick.mark@glasgow.ac.uk
Patrick Mark, MBChB
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.
- 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
- 13 Feb 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.