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Developing methods for reconstructing electrical heart activity.


- candidate number10226
- NTR NumberNTR3016
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-aug-2011
- Secondary IDsNL32128.068.11 CCMO
- Public TitleDeveloping methods for reconstructing electrical heart activity.
- Scientific TitleDeveloping mathematical methods for non-invasive reconstruction of electrical heart activity from body-surface electrocardiograms and a CT-based torso-heart geometry.
- ACRONYM
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedHearth rhythm disorders
- Inclusion criteriaAge ≥ 18 years and one or more of the following:
1. Conditions that might alter electrical conduction properties in the heart, including (but not limited to): Brugada syndrome (BS), Arrhythmogenic right ventricular cardiomyopathy (ARVC);
2. Implanted cardiac device, such as pacemaker or implantable cardioverter defibrillator;
3. The sole need for cardiac CT as technique to exclude cardiac disease (reference group).
- Exclusion criteriaKnown strong reaction against electrode attachment.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-sep-2011
- planned closingdate1-sep-2016
- Target number of participants65
- InterventionsThe subjects will be asked to undergo a procedure in which 256 recordings of body-surface potentials (ECGs) are made. For this purpose, strips of electrodes will be attached to the subject's torso. When the patient (for diagnostic reasons unrelated to this research) will receive a cardiac CT scan, this will be extended to also image the body-surface electrodes.
- Primary outcomeThe primary study endpoint is further development and validation of mathematical methods and recording techniques, to reconstruct epicardial potentials from body-surface potentials (BSPs) and a torso-heart geometry. This development and validation can only be performed when BSP and torso-heart geometrical data are available.
- Secondary outcomeThe secondary study endpoints include disease-specific abnormalities in epicardial reconstructions or in body-surface potential maps.
- TimepointsRecording of body-surface potentials and (if applicable) a CT scan at timepoint 1. Follow-up might follow at a later timepoint, at which body-surface potentials will be re-recorded.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Paul Volders
- CONTACT for SCIENTIFIC QUERIESDr. Paul Volders
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Heart Foundation (Nederlandse Hartstichting), Maastricht University Medical Center (MUMC+)
- PublicationsN/A
- Brief summaryNon-invasive reconstruction of electrical heart activity can yield important scientific and clinical insights in cardiac rhythm disorders. In this study, we aim at developing methods for reconstructing electrical heart activity non-invasively, and to use these methods to investigate cardiac rhythm disorders to answer clinical and scientific questions.
- Main changes (audit trail)
- RECORD8-aug-2011 - 21-okt-2011


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