Spanish Registry of Patients With Implantable Cardiac Devices That Require a Diagnostic Imaging Test With Nuclear Magnetic Resonance
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,248
- 试验地点
- 20
- 主要终点
- Percentage of patients with implantable cardiac devices that require a diagnostic test based on MRI
研究概览
简要总结
The general objective of this registry is to study the number of patients carrying an implantable cardiac device that have an indication for an imaging diagnosis based on nuclear magnetic resonance. Is wanted to know the cause of the indication of the diagnostic test based on MRI.
详细描述
MRI is currently infra indicated in patients with cardiac stimulation devices and for this reason, the request for this imaging technique in these patients is complicated and, often, the MRI-based test is replaced by a CT scan that may not be so beneficial for the diagnosis.
Current data indicate that, with cardiological control and maintaining basic safety precautions, MRI could be performed in patients with peacemakers and Implantable Cardioverter Defibrillators (ICD) that require it for clinical reasons, although it should be noted that currently, due to lack of data published, the absolute safety of an MRI in these patients and the protocol used in each case cannot be guaranteed.
This registry proposal is to have data of all patients implanted with Biotronik cardiac stimulation devices and evaluate how many of them have an indication for an MRI-based diagnostic test, how many of them are already undergoing this diagnostic test, how many are given an tomography as an alternative to avoid subjecting patients to an MRI
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients carrying a cardiac stimulation device
- •Patients able to understand the nature of the procedure
- •Patients who give informed consent
排除标准
- •Epicardial cables
- •Abandoned cables
- •Non-BIOTRONIK cables
- •Age <18 years
- •Pregnant and breastfeeding
- •Subjects with irreversible brain damage caused by a pre-existing brain disease
- •Heart transplant 6 months prior to recruitment or expected within the next 3 months
- •Cardiac surgery 3 months prior to recruitment or planned for the next 3 months
- •Life expectancy less than 12 months
结局指标
主要结局
Percentage of patients with implantable cardiac devices that require a diagnostic test based on MRI
时间窗: 1 year
statistical analysis of the variable
次要结局
- Primary indication for MRI(1 year)
- Percentage of patients with a non-MRI-based test diagnosis, although they had an indication for an MRI-based diagnostic test because of their disease(1 year)
- Cost effectiveness of the he MRI Autodetect function(1 year)
- Reasons for not used MRI(1 year)
- Analysis of the differences in the workflow(1 year)