Back to resultsDeveloping Methods for Reconstructing Electrical Heart Activity
Primary Purpose
Heart Diseases, Cardiac Conduction Defect
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Computed tomography (CT) scan
Body-surface potential mapping
Sponsored by
About this trial
This is an interventional basic science trial for Heart Diseases focused on measuring Electrocardiography, Body Surface Potential Mapping, Computational Biology
Eligibility Criteria
Overall Inclusion Criteria:
- 18 years or older
- able to provide informed consent
- Conditions that might alter electrical conduction properties in the heart, including (but not limited to): Brugada syndrome (BS), Arrhythmogenic right ventricular cardiomyopathy (ARVC), demonstrated ventricular arrhythmias (resuscitation, (non)sustained ventricular tachycardia, ventricular fibrillation)
- Implanted cardiac device, such as pacemaker or implantable cardioverter defibrillator
Additional Inclusion Criteria for group 1 (CT group):
- Existing medical indication for a cardiac CT scan unrelated to this research
There are no additional inclusion criteria for group 2 (no-CT group).
Exclusion Criteria:
- Known strong reaction against electrode attachment
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BSPM-only group
CT+BSPM group
Arm Description
Participants will only receive body-surface potential mapping (BSPM) with an extensive electrode set (256 electrodes).
Participants will receive body-surface potential measurements (BSPM) and a CT scan. These data will allow for non-invasive reconstruction of electrical potentials at the heart surface.
Outcomes
Primary Outcome Measures
Epicardial potentials
Primary outcome data include reconstructed electrical heart activity such as:
- epicardial potentials (units: millivolts [mV])
These outcome data are obtained at the moment of inclusion.
The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records:
- Reconstructed epicardial potentials (mV) will be compared to selected invasive epicardial potentials (mV) obtained from catheter-based recordings or pacemaker-based recordings available as clinical data
Epicardial electrograms
Primary outcome data include reconstructed electrical heart activity such as:
- epicardial electrograms (units: millivolts [mV] over milliseconds [ms])
These outcome data are obtained at the moment of inclusion.
The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records:
- Reconstructed electrograms (mV) will be compared to selected invasive epicardial electrograms (mV) obtained from catheter-based recordings or pacemaker-based recordings available as clinical data
Epicardial activation and recovery sequences
Primary outcome data include reconstructed electrical heart activity such as:
- epicardial activation and recovery isochrones (units: milliseconds [ms])
These outcome data are obtained at the moment of inclusion.
The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records:
- Reconstructed activation and recovery sequences (ms) will be compared to recorded catheter-based sequences from clinical data (ms).
Secondary Outcome Measures
Disease-specific differences in primary outcome measures
The secondary study endpoints include disease-specific differences of the primary outcome measures, which may include abnormal (low-amplitude, fractionated) electrograms and abnormal activation and recovery sequences. Depending on the primary measure, these differences will be expressed in absolute units (mV, ms) or relative differences (%).
Full Information
NCT ID
NCT03947021
First Posted
November 21, 2012
Last Updated
September 7, 2021
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03947021
Brief Title
Developing Methods for Reconstructing Electrical Heart Activity
Official Title
Developing Mathematical Methods for Non-invasive Reconstruction of Electrical Heart Activity From Body-surface Electrocardiograms and a CT-based Torso-heart Geometry
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Non-invasive reconstruction of electrical heart activity can yield important scientific and clinical insights in cardiac rhythm disorders. In this study, The investigators 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Cardiac Conduction Defect
Keywords
Electrocardiography, Body Surface Potential Mapping, Computational Biology
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BSPM-only group
Arm Type
Experimental
Arm Description
Participants will only receive body-surface potential mapping (BSPM) with an extensive electrode set (256 electrodes).
Arm Title
CT+BSPM group
Arm Type
Experimental
Arm Description
Participants will receive body-surface potential measurements (BSPM) and a CT scan. These data will allow for non-invasive reconstruction of electrical potentials at the heart surface.
Intervention Type
Radiation
Intervention Name(s)
Computed tomography (CT) scan
Intervention Description
A CT scan of thorax and heart will be performed in the CT+BSPM group.
Intervention Type
Device
Intervention Name(s)
Body-surface potential mapping
Intervention Description
Measurement of 256-lead body-surface electrocardiogram
Primary Outcome Measure Information:
Title
Epicardial potentials
Description
Primary outcome data include reconstructed electrical heart activity such as:
- epicardial potentials (units: millivolts [mV])
These outcome data are obtained at the moment of inclusion.
The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records:
- Reconstructed epicardial potentials (mV) will be compared to selected invasive epicardial potentials (mV) obtained from catheter-based recordings or pacemaker-based recordings available as clinical data
Time Frame
Day one, direct measurement
Title
Epicardial electrograms
Description
Primary outcome data include reconstructed electrical heart activity such as:
- epicardial electrograms (units: millivolts [mV] over milliseconds [ms])
These outcome data are obtained at the moment of inclusion.
The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records:
- Reconstructed electrograms (mV) will be compared to selected invasive epicardial electrograms (mV) obtained from catheter-based recordings or pacemaker-based recordings available as clinical data
Time Frame
Day one, direct measurement
Title
Epicardial activation and recovery sequences
Description
Primary outcome data include reconstructed electrical heart activity such as:
- epicardial activation and recovery isochrones (units: milliseconds [ms])
These outcome data are obtained at the moment of inclusion.
The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records:
- Reconstructed activation and recovery sequences (ms) will be compared to recorded catheter-based sequences from clinical data (ms).
Time Frame
Day one, direct measurement
Secondary Outcome Measure Information:
Title
Disease-specific differences in primary outcome measures
Description
The secondary study endpoints include disease-specific differences of the primary outcome measures, which may include abnormal (low-amplitude, fractionated) electrograms and abnormal activation and recovery sequences. Depending on the primary measure, these differences will be expressed in absolute units (mV, ms) or relative differences (%).
Time Frame
Day one, direct measurement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Overall Inclusion Criteria:
18 years or older
able to provide informed consent
Conditions that might alter electrical conduction properties in the heart, including (but not limited to): Brugada syndrome (BS), Arrhythmogenic right ventricular cardiomyopathy (ARVC), demonstrated ventricular arrhythmias (resuscitation, (non)sustained ventricular tachycardia, ventricular fibrillation)
Implanted cardiac device, such as pacemaker or implantable cardioverter defibrillator
Additional Inclusion Criteria for group 1 (CT group):
- Existing medical indication for a cardiac CT scan unrelated to this research
There are no additional inclusion criteria for group 2 (no-CT group).
Exclusion Criteria:
- Known strong reaction against electrode attachment
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Developing Methods for Reconstructing Electrical Heart Activity
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