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出境医 / 临床实验 / Developing Methods for Reconstructing Electrical Heart Activity
Developing Methods for Reconstructing Electrical Heart Activity
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Diseases Cardiac Conduction Defect | Radiation: Computed tomography (CT) scan Device: Body-surface potential mapping | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 65 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Developing Mathematical Methods for Non-invasive Reconstruction of Electrical Heart Activity From Body-surface Electrocardiograms and a CT-based Torso-heart Geometry |
| Actual Study Start Date : | January 2012 |
| Estimated Primary Completion Date : | March 2021 |
| Estimated Study Completion Date : | March 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: BSPM-only group
Participants will only receive body-surface potential mapping (BSPM) with an extensive electrode set (256 electrodes).
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Device: Body-surface potential mapping
Measurement of 256-lead body-surface electrocardiogram
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Experimental: CT+BSPM group
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.
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Radiation: Computed tomography (CT) scan
A CT scan of thorax and heart will be performed in the CT+BSPM group.
Device: Body-surface potential mapping Measurement of 256-lead body-surface electrocardiogram
|
Outcome Measures
Primary Outcome Measures :
- Epicardial potentials [ Time Frame: Day one, direct measurement ]
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 [ Time Frame: Day one, direct measurement ]
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 [ Time Frame: Day one, direct measurement ]
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 [ Time Frame: Day one, direct measurement ]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 (%).
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Locations
| Netherlands | |
| Maastricht University Medical Center | |
| Maastricht, Netherlands | |
Sponsors and Collaborators
Maastricht University Medical Center
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | November 21, 2012 | ||
| First Posted Date ICMJE | May 13, 2019 | ||
| Last Update Posted Date | September 2, 2020 | ||
| Actual Study Start Date ICMJE | January 2012 | ||
| Estimated Primary Completion Date | March 2021 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | |||
| Current Secondary Outcome Measures ICMJE |
Disease-specific differences in primary outcome measures [ Time Frame: Day one, direct measurement ] 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 (%).
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| Original Secondary Outcome Measures ICMJE | Same as current | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Developing Methods for Reconstructing Electrical Heart Activity | ||
| Official Title ICMJE | Developing Mathematical Methods for Non-invasive Reconstruction of Electrical Heart Activity From Body-surface Electrocardiograms and a CT-based Torso-heart Geometry | ||
| 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. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Not Applicable | ||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Active, not recruiting | ||
| Estimated Enrollment ICMJE |
65 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date ICMJE | March 2022 | ||
| Estimated Primary Completion Date | March 2021 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE |
Overall Inclusion Criteria:
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 |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | Yes | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Netherlands | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT03947021 | ||
| Other Study ID Numbers ICMJE | METC 11-2-043 NHS 2007T51 ( Other Grant/Funding Number: Netherlands Heart Foundation ) |
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| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Maastricht University Medical Center | ||
| Study Sponsor ICMJE | Maastricht University Medical Center | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Maastricht University Medical Center | ||
| Verification Date | August 2020 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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