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临床试验/NCT03081364
NCT03081364已完成不适用

Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices

Saint Luke's Health System0 个研究点目标入组 532 人开始时间: 2015年9月最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

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