Cardiovascular Diseases Clinical Trial
— CRAFT-CTCAOfficial title:
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
NCT number | NCT06234410 |
Other study ID # | TCS/22/09 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 24, 2024 |
Est. completion date | January 2032 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | Lothian |
United Kingdom | Queen Elizabeth Hospital | Glasgow |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | Chief Scientist Office of the Scottish Government, NHS Greater Glasgow and Clyde, NHS Lothian, University of Glasgow |
United Kingdom,
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 |
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