Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 532
- 主要终点
- Change in blood pressure
研究概览
简要总结
The investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac Implanted Electronic Devices)
详细描述
At Saint Luke's Hospital, despite growing evidence to the contrary, there is extremely limited data and experience with performing MRIs on patient with abandoned and epicardial leads in patients with non-approved ICDs and PMs. There is a limited mechanism to discuss this issue with the patient, screen the patient and assess their device beforehand, monitor them during the MRI examination, keep track of pulse sequences used, assess their devices after (and if necessary, resume prior programming before any changes), and to maintain that experience. The objective of this study is to create a protocol for an MRI at the commonly used magnetic strength of 1.5 T in patients that do not have conditional pacemakers and/or defibrillators and have abandoned or epicardial leads and maintain a registry of participants, devices involved, MRI examinations and pulse sequences used, and to keep records of any follow up events.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anyone with a cardiac device
排除标准
- •Anyone who cannot consent for themselves or who don't have a durable power of attorney
结局指标
主要结局
Change in blood pressure
时间窗: 3 years
Monitored with automatic blood pressure cuff
Change in heart rate
时间窗: 3 years
Measured as beats per minute on single-lead heart monitor.
Change in Device Function
时间窗: 3 years
Change in lead impedance or sensing
Oxygen Saturation
时间窗: 3 years
Percentage of change or no change
Patient Comments
时间窗: 3 years
Real-time patient report via intercom during scan of chest symptoms such as burning or aching
Change in Thresholds of Pacing Lead
时间窗: 3 years
Measured in mA
Dysrhythmias Noted During Scan
时间窗: 3 years
Change in heart rhythm
Interference Between the Implanted Cardiac Electronic Device and MRI
时间窗: 3 years
Measure any change in device battery voltage
次要结局
未报告次要终点
