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| Name | Class |
|---|---|
| Chief Scientist Office of the Scottish Government | OTHER_GOV |
| University of Glasgow | OTHER |
| NHS Lothian | OTHER_GOV |
| NHS Greater Glasgow and Clyde |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients waitlisted for kidney transplantation | Patients who have been placed on the waiting list for a kidney transplant within Scotland |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed tomography coronary angiography (CTCA) | Radiation | Single CTCA scan prior to kidney transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of participants who are hospitalised due to any cardiovascular event |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of participants who have clinically significant abnormal non-cardiac findings on study CTCA scan |
Inclusion Criteria:
Exclusion Criteria:
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Patients on the kidney transplant waitlist
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gavin B Chapman, MBChB | Contact | 00447713349318 | gchapma2@ed.ac.uk | |
| Neeraj Dhaun, MBChB | Contact | bean.dhaun@ed.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Neeraj Dhaun, MBChB | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary of Edinburgh | Recruiting | Edinburgh | Lothian | EH16 4SA | United Kingdom |
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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| OTHER |
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Serum and plasma (including for potential genetic analysis) will be taken from participants and stored.
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) | 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 | 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 |
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 |
| Queen Elizabeth Hospital | Not yet recruiting | Glasgow | G51 4TF | United Kingdom |
|
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003324 | Coronary Artery Disease |
| D006331 | Heart Diseases |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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