Evaluation of MRI-conditional 12-lead ECG
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- absolute numbers and percentages
研究概览
简要总结
With MRI's increasing role in detecting central nervous system and orthopedic diseases, patients with ischemic history are increasingly referred for MRI exams. Currently, 3-lead ECG gating systems are utilized during cardiac MRI scanning as standard of care. However, this monitoring system is often insufficient to evaluate for the development of important arrhythmias or ischemia during MRI scanning. Morevoer, MRI associated magnetic fields and radio frequency pulses can produce interference in the ECG signal that leads to non-diagnostic ECG signals. MiRTLE Medical, a Massachusetts-based medical device company, has developed a high-fidelity, MRI-conditional 12-lead ECG monitoring system. This 12-lead ECG system is a first of its kind that addresses the MRI-induced interference and safety issues. This study is to evaluate the efficacy of this 12-lead ECG system in the clinical setting. The investigators hope that this system will be helpful for image-guided therapeutics especially electrophysiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age and older
- •Atrial fibrillation
- •Provision of informed consent
- •Eligible for the Ontario Health Insurance Plan
排除标准
- •Failure to provide informed consent
- •Pregnant women
- •CMR contra-indicated
- •Hemodynamically unstable
- •Permanent pacemaker/ICD
- •Aneurysm clip/carotid artery vascular clamp
- •Claustrophobic
研究组 & 干预措施
12-Lead ECG
The study group patients will have MRI with 12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical
干预措施: 12-lead ECG monitoring device (MiRTLE Medical) (Device)
3-lead ECG gating system
the control group will have MRI with 3-lead ECG gating which is standard of care.
干预措施: 3-lead ECG gating system (Device)
结局指标
主要结局
absolute numbers and percentages
时间窗: up to 6 weeks
the following patient data will be collected as absolute numbers and percentages in a future Table 1: Age, Sex, Cardiovascular Risk Factors (DM, HTN, Dyslipidemia, smoking, family history of cardiovascular disease), Atrial fibrillation risk factors (CHADS-2 score; CHF, Age \>75, DM, prior stroke/CVA), Prior atrial fibrillation ablation procedures, echocardiographic parameters (LVEF, Left atrial size), MRI parameters (Left ventricular end-diastolic volume, left ventricular end systolic volume, left ventricular stroke volume, LVEF, left atrial volume, right ventricular volumes and ejection fraction.)
qualitatively comparison with a standard scale
时间窗: up to 6 weeks
qualitatively comparison will be done for ECG signal quality and artifact between the 12-lead and 3-lead ECG arms using a standard scale. A 5 point Likert scale will be used with the below scores: 1. indicating 12-lead ecg quality is substantially worse than 3-lead ecg 2. somewhat worse 3. equivalent 4. somewhat better 5. significantly better
次要结局
未报告次要终点
研究者
Dr. Graham Wright
Senior scientist
Sunnybrook Health Sciences Centre