NCT02357082已完成不适用
Mayo Clinic Cardiac Implantable Electronic Device (CIED) Magnetic Resonance Imaging (MRI) Registry; Determining the Risks of of MRI in the Presence of Cardiac Implantable Electronic Devices
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- P/R Wave Amplitude at Different Timepoints
研究概览
简要总结
Registry intends to prospectively collect data regarding the safety of magnetic resonance imaging (MRI) studies in patients with cardiac pacemakers on implantable cardioverter defibrillators.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Strong clinical indication for MRI; in the clinical setting where MRI is the diagnostic modality of choice for a specific disease state without acceptable alternative imaging technology
- •Male or Female
- •18 years of age or older
- •Able to provide informed consent
- •Presence of CIED
排除标准
- •Presence of metallic objects that represent a contraindication to MR imaging, including: MRI-unsafe intra-orbital or intra-ocular retained metal fragments, and MRI-unsafe intracranial vascular clips and coils, other MRI-unsafe devices
- •Morbid obesity (abdominal diameter greater than 60 centimeters) which results in contact wiht the magnet bore.
- •Pregnant at time of scanning Pacemaker or Implanted Cardiac Device that is labeled as MRI-Conditional (approved by the Food and Drug Administration for exposure to MRI)
- •Pacemaker dependent and either: 1) device implanted before 2005, or 2) advisory pulse generator that may lower outputs in the setting of radiofrequency currents
结局指标
主要结局
P/R Wave Amplitude at Different Timepoints
时间窗: Baseline, Visit 1, 3 months, 6 months
Cardiac Implantable Electronic Device Lead Impedance at Different Timepoints
时间窗: Baseline, Visit 1, 3 months, 6 months
Cardiac Implantable Electronic Device Lead Threshold at Different Timepoints
时间窗: Baseline, Visit 1, 3 months, 6 months
次要结局
未报告次要终点
研究者
Robert E. Watson
Principal Investigator
Mayo Clinic
研究点 (1)
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