Validating Novel, Non-contrast Cardiac MRI Imaging in Haemodialysis Patients
NCT ID: NCT03586518
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
9 participants
OBSERVATIONAL
2019-11-03
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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:
* Prevalent haemodialysis patient (more than 3 months)
* Active on the supportive care register with anticipated death in the subsequent 12 months
* Able to give informed consent
* Consent to donation of heart for research following death
* Able to understand written and verbal explanations in English
Exclusion:
* Contraindication to MRI scan (e.g. pacemaker, incompatible metallic implants, claustrophobia)
* Patients with expected or potential infiltrative cardiomyopathy (e.g. amyloidosis)
* Unable to give informed consent
* Unable to understand written and verbal explanations in English
Cardiac MRI scan
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.
Echocardiogram
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.
Cardiac explantation
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
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.
Blood samples
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.
Interventions
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Cardiac MRI scan
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.
Echocardiogram
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.
Cardiac explantation
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
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.
Blood samples
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active on the supportive care register with anticipated death in the subsequent 12 months
* Able to give informed consent
* Consent to donation of heart for research following death
* Able to understand written and verbal explanations in English
Exclusion Criteria
* Patients with expected or potential infiltrative cardiomyopathy (e.g. amyloidosis)
* Unable to give informed consent
* Unable to understand written and verbal explanations in English
18 Years
ALL
No
Sponsors
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University Hospitals, Leicester
OTHER
St George's, University of London
OTHER
University of Leicester
OTHER
Responsible Party
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Principal Investigators
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James Burton, DM, FRCP
Role: PRINCIPAL_INVESTIGATOR
Associate Professor in Renal Medicine
Locations
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University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0674
Identifier Type: -
Identifier Source: org_study_id
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