A Multi-centre Observational Cohort Trial to Identify Magnetocardiography (MCG) Parameters in the Prediction of Future ICD Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Number of participants with features of heterogenous myocardial conduction (eg. late QRS signals, QT dispersion) and correlation with ventricular arrhythmias as reported by ICD interrogation
研究概览
简要总结
A multi-centre observational cohort trial to identify Magnetocardiography (MCG) parameters in the prediction of future ICD therapy. To show a correlation between Arrhythmogenic features on MCG and future ICD therapies seen on ICD interrogation of patients at risk of SCD.
详细描述
AIM: To explore if VitalScan MCG parameters are able to predict future ICD therapies in patients who meet the requirements for ICD therapy.
Magnetocardiography (MCG) Magnetocardiography (MCG) is a non-invasive, non-contact body-surface method which uses magnetometers to measure and map the magnetic fields generated by the electrical activity within the heart. It offers a better spatial resolution than an ECG recording and opens the possibility of detecting conduction characteristics consistent with arrhythmogenesis.
The application of MCG has been limited by feasibility as devices up to now have been based on superconducting quantum interference devices (SQUID) with super cooled sensors. These machines were often operated in a shielded environment, to decrease magnetic field interference (noise) from electrical devices and other sources of magnetic fields. This was a major limiting factor in deploying these devices in a working environment especially considering, that most hospital wards will have numerous devices that can interfere with the device.
The investigators will be evaluating the use of a portable magnetometer which measures the change in magnetic fields rather than an absolute magnetic field as measured by SQUID magnetometers used in the trials mentioned above. It has been developed to be more affordable and more feasible than SQUID magnetometers as it is designed to be operated at room temperature in an unshielded environment. The investigators will be evaluating its ability to measure parameters identified in previous literature as well as other novel parameters that may be identified from acquiring the MCG derivative. With the development of this portable magnetometer designed to be used in an unshielded environment, there is real potential for screening a large numbers of patients for SCD risk. Until this trial, this novel tool has not been evaluated in this role.
MCG parameters in Sudden Cardiac Death (SCD) Whilst there are limited data on the role of MCG in predicting arrhythmic events, a series of studies involving patients with ischaemic heart disease have shown a correlation between MCG characteristics and the presence of ventricular arrhythmias. Specifically QRS fragmentation and late fields of the QRS have been associated with a higher incidence of ventricular arrhythmia. A trial of 49 patients with dilated cardiomyopathy demonstrated parameters present on MCG scans which were able to distinguish between participants, retrospectively, who had a ventricular arrhythmia in comparison to those who did not. The authors associated the features in the MCG T wave (specifically prolongation of the end part of the T wave) with the presence of ventricular arrhythmias. Kawakami et al prospectively studied ventricular arrhythmia risk in 51 patients with non-ischaemic cardiomyopathy for a mean follow-up of 2.9 years. They found that MCG left intraventricular disorganised conduction described as a deviation from the typical global clockwise LV depolarisation was predictive of major adverse cardiac events..
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 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
- •All patients referred to the cardiology team who meet the following criteria will be invited to participate in the trial:
- •Age: 18 years or over
- •Can give informed consent
排除标准
- •- Patients unable to lie still on a bed at a maximum of 30 degree angle for 5 minutes
- •Patients with ongoing myocardial infarction or active ischaemia.
- •Clinically unstable patients as determined by their treating clinician.
- •Patients with existing thoracic metallic implants ie. pacing or defibrillator device, metallic valve will be excluded from the main arm of the trial. The research team will perform a side arm (Device in situ group) trial on 30 participants with either ICDs or pacemakers.
- •Age: Under 18 years.
结局指标
主要结局
Number of participants with features of heterogenous myocardial conduction (eg. late QRS signals, QT dispersion) and correlation with ventricular arrhythmias as reported by ICD interrogation
时间窗: 12-72 months
We will remotely follow up participants who have had ICD and observe if they have had an ICD interrogation (Shock) for arrythmogenic events. These are defined by ventricular rates that are faster than 149 beats per minute and deemed to be ventricular in origin on ICD interrogation during standard follow up. We will the compare the MCG scans of participants who had shock with that of whom did not.
次要结局
- Exploring the correlation between ECG parameters, Echo findings, MCG parameters and ICD therapies.(12-72 months)
- Correlation of MCG parameters with Left ventricular ejection fraction (LVEF)(Baseline)
- Exploring the correlation of MCG QRS fragmentation and current flow analysis with ICD therapies(12-72 months)
- Analysis of the SF-36 quality of life questionnaire results(12 month follow up)
