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| Name | Class |
|---|---|
| University Hospitals, Leicester | OTHER |
| St George's, University of London | OTHER |
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There are currently no good ways of measuring levels of scarring in the hearts of patients with advanced kidney disease and patients on dialysis, although recent research has shown a new cardiac MRI technique, called native T1 mapping, may provide a solution to this. To assess the accuracy of this novel technique in dialysis patients, it is essential to undertake a study which compares native T1 mapping to actual levels of scarring in the hearts of patients on dialysis.
Native T1 mapping is a novel, non-contrast, cardiac MRI technique that characterises myocardial tissue by exploiting the different water content of tissues. It correlates well with histo-pathological levels of myocardial fibrosis in diseases of pressure overload such as aortic stenosis. There is growing evidence to demonstrate the potential of native T1 mapping as an imaging biomarker of myocardial fibrosis in patients with ESRD; myocardial native T1 values are higher in patients with ESRD than controls, and associate with measures of myocardial strain and circulating markers of cardiac dysfunction. Although native T1 times are affected by water content of tissues, our group has shown that native T1 times are not influenced by clinical changes in fluid status in HD patients and that the inter-study reproducibility and intra- and inter-observer variability of native T1 are outstanding.
Native T1 mapping is a promising, non-invasive imaging biomarker of myocardial fibrosis in patients with advanced renal disease. It is essential that the technique is validated against histology before further use in clinical studies.
The aim of this study is to directly assess the relationship between native T1 mapping and levels of MF examined at post-mortem in haemodialysis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haemodialysis patients | The plans for patient recruitment were developed in partnership with our local haemodialysis patient participation and involvement group. Patients will be identified from the supportive care register established for haemodialysis patients in Leicester in 2008. Inclusion:
Exclusion:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac MRI scan | Diagnostic Test | A non-contrast cardiac MRI (CMR) scan at 3-Tesla platform (Skyra, Siemens Medical Imaging, Erlangen, Germany). This non-contrast CMR scan will principally determine: Left ventricular (LV) mass and volumes/ejection fraction and; fibrosis using T1 mapping. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between MRI and histological measures of cardiac fibrosis | To assess the correlation between native T1 values measured using cardiac MRI in haemodialysis patients approaching the end of their lives, with histological samples analysed post-mortem. | Cardiac MRI performed within 12-months of histological samples obtained post-mortem |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of MRI versus ECHO in the measurement of cardiac fibrosis | Relationship between integrated backscatter (measured with echocardiography) and levels of myocardial fibrosis on histology measured at post-mortem. | Echocardiograms performed within 12-months of histological samples obtained post-mortem |
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Inclusion Criteria:
Exclusion Criteria:
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The plans for patient recruitment were developed in partnership with our local haemodialysis patient participation and involvement group. Patients will be identified by means of a well established supportive care register for haemodialysis patients. These patients, and often their families, have engaged in discussion about end-of-life care, including discussions about limitations on care and preferred place of death.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Burton, DM, FRCP | Contact | +44 (0)116 2588043 | jb343@le.ac.uk | |
| Matthew Graham-Brown, MBChB, MRCP | Contact | +44 (0)116 2588043 | mgb23@le.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| James Burton, DM, FRCP | Associate Professor in Renal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leicester NHS Trust | Recruiting | Leicester | Leicestershire | LE5 4PW | United Kingdom |
The full study protocol will be published online, open access.
The protocol will be published within 12 months of registration.
Open access.
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D009205 | Myocarditis |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D015716 | Electrocardiography, Ambulatory |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Patient hearts explanted post-mortem
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| Echocardiogram | Diagnostic Test | Assessments will include: LV size and function as per the American Society of Echocardiography guidelines. In addition specific focus will be paid end-diastolic integrated backscatter measurements. |
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| Cardiac explantation | Procedure | A limited post-mortem will be performed to retrieve patients' hearts for preparation and storage at St George's University, London where direct comparison will be made between levels of scarring seen directly under the microscope between that on the MRI scans. |
|
| 48-Hour continuous cardiac monitoring | Diagnostic Test | Attach continuous Holter monitor (Schiller, medilog®AR12 plus/AR4 plus/FD5 plus, Baar, Switzerland) that will start before dialysis and terminate just before the subsequent dialysis treatment 48h later. |
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| Blood samples | Diagnostic Test | Collect blood samples from the arterial needle before dialysis. Approximately 30 millilitres of blood will be collected and then be pipetted into cryotubes and frozen at -80°C in an electronically monitored freezer for analysis in batches throughout the study. These samples will be used to investigate the relationship between circulating biomarkers of fibrosis, the MRI scans and the histological samples. |
|
| Relationship between cardiac fibrosis and heart rhythm |
Relationship between continuous Holter-monitor data and levels of myocardial fibrosis on histology measured at post-mortem. |
| Continuous Holter recording performed within 12-months of histological samples obtained post-mortem |
| Correlation between cardiac fibrosis and relevant circulating biomarkers | Relationship between humoral markers of cardiac dysfunction of fibrosis and levels of myocardial fibrosis on histology measured at post-mortem | Samples collected within 12-months of histological samples obtained post-mortem |
| Additional cardiac MRI techniques and the measurement of cardiac fibrosis | The relationship between additional, non-contrast CMR techniques and histology at post-mortem | Cardiac MRI performed within 12-months of histological samples obtained post-mortem |
| 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 |
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D004562 | Electrocardiography |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |