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临床试验/NCT03947021
NCT03947021Unknown不适用

Developing Mathematical Methods for Non-invasive Reconstruction of Electrical Heart Activity From Body-surface Electrocardiograms and a CT-based Torso-heart Geometry

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
65
试验地点
1
主要终点
Epicardial potentials

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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).

排除标准

  • •Known strong reaction against electrode attachment

研究组 & 干预措施

BSPM-only group

Experimental

Participants will only receive body-surface potential mapping (BSPM) with an extensive electrode set (256 electrodes).

干预措施: Body-surface potential mapping (Device)

CT+BSPM group

Experimental

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.

干预措施: Computed tomography (CT) scan (Radiation)

CT+BSPM group

Experimental

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.

干预措施: Body-surface potential mapping (Device)

结局指标

主要结局

Epicardial potentials

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

  • Disease-specific differences in primary outcome measures(Day one, direct measurement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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