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

Cardiovascular Diseases Clinical Trial

— CRAFT-CTCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234410
• Other study ID #: TCS/22/09
• Status: Recruiting
• Start date: January 24, 2024
• Est. completion date: January 2032

Study information

• Verified date: January 2024
• Source: University of Edinburgh
• Contact: Gavin B Chapman, MBChB
• Phone: 00447713349318
• Email: gchapma2[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 332
• Est. completion date: January 2032
• Est. primary completion date: January 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Kidney Transplant; Complications

Intervention

Radiation:
• Computed tomography coronary angiography (CTCA)
Single CTCA scan prior to kidney transplantation

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Lothian
United Kingdom	Queen Elizabeth Hospital	Glasgow

Sponsors (5)

Lead Sponsor	Collaborator
University of Edinburgh	Chief Scientist Office of the Scottish Government, NHS Greater Glasgow and Clyde, NHS Lothian, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants who suffer a clinically significant acute kidney injury following study CTCA scan	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
Other	Number of participants who have clinically significant abnormal non-cardiac findings on study CTCA scan	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
Primary	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	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.	From time of CTCA scan to 36- and 60-months follow-up
Secondary	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)	From time of CTCA scan to 36- and 60-months follow-up
Secondary	Number of participants who die (all-cause death)	Death due to any cause	From time of CTCA scan to 36- and 60-months follow-up
Secondary	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)	From time of CTCA scan to 36- and 60-months follow-up