The Arrhythmogenic Potential of Midwall Septal Fibrosis in Dilated Cardiomyopathy
NCT ID: NCT05026112
Last Updated: 2022-03-31
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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UNKNOWN
120 participants
OBSERVATIONAL
2021-10-01
2024-10-01
Brief Summary
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Access to the epicardium for electrical measurements of the heart can enhance the understanding of arrhythmogenicity in DCM, however direct epicardial access is invasive. Instead, the investigators will non-invasively combine high resolution 256-lead ECG imaging (ECGI) and latest generation cardiovascular magnetic resonance (CMR) to study the hearts of 60 DCM patients with and without MSF regardless of LVEF, and 60 matched healthy volunteers. The investigators recently invented the re-usable and CMR-safe SMART-ECGI vest technology for this purpose. Using supercomputers, the investigators will fuse the collected ECGI/CMR data and run electromechanical simulations of whole-heart activation to non-invasively measure each participant's personalised risk of malignant VA induction.
By panoramically mapping the DCM heart in a single beat, the investigators aim to elucidate how MSF perturbs the cardiac activation front and how this could lead to life-threatening VA. This has the potential to change the method by which cardiologists risk stratify patients with DCM.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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DCM with MSF (MSF+)
Patients with dilated cardiomyopathy and midwall septal fibrosis identified in a previous cardiac MRI scan
ECG-Imaging
ECG imaging acquisition
Cardiac MRI scan
Cardiac MRI scan
DCM without MSF (MSF-)
Patients with dilated cardiomyopathy but without midwall septal fibrosis on previous cardiac MRI scan
ECG-Imaging
ECG imaging acquisition
Cardiac MRI scan
Cardiac MRI scan
Control - MSF+
Control healthy volunteers (HV) to the MSF+ cohort
ECG-Imaging
ECG imaging acquisition
Cardiac MRI scan
Cardiac MRI scan
Control - MSF-
Control healthy volunteers (HV) to the MSF- cohort
ECG-Imaging
ECG imaging acquisition
Cardiac MRI scan
Cardiac MRI scan
Interventions
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ECG-Imaging
ECG imaging acquisition
Cardiac MRI scan
Cardiac MRI scan
Eligibility Criteria
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Inclusion Criteria
* With and without midwall septal fibrosis on previous CMR
Exclusion Criteria
* anyone unwilling to consent
* anyone with a conventional contraindication for CMR
* anyone with any condition precluding full participation in the study such as DCM patients with infarct-pattern LGE, or subepicardial LGE or non-septal midwall fibrosis (participants with small volume right ventricular insertion point LGE will not be excluded).
18 Years
ALL
Yes
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Gabriella Captur, PhD
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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Royal Free Hospital NHS Trust (RFH)
London, , 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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143656
Identifier Type: -
Identifier Source: org_study_id
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