Use of a New ElectroCardioGraph to Create an ECG Database in 3T MRI With Healthy Heart and Several Kind of Cardiac Disease in Order to Let go of Artifacts.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Evaluation of the ECG signal quality
研究概览
简要总结
The aim is to create a database including recordings of ECG data recorded in an MRI acquisition
详细描述
ECG monitoring is an essential tool during MRI, especially for cardiac MRI (CMR). Indeed, the system needs to synchronize the acquisitions on the cardiac cycles. To identify the cycle, the system is based on the ECG. Furthermore, patients having a CMR can be at risk of presenting cardiac rhythm troubles, and must be monitored with a trustable system.
The problem is that in MRI, a lot of artefacts occur, leading to dramatic disturbances of the signal. A lot of tools are used to try to remove the artefacts. The aim of this study is to create a database that can be used to test the different tools to remove the artefacts.
The investigators intend to include all types of ECG patterns that can exist, to allow to test the tools in all situations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For all subjects:
- •To be more than 18
- •To be enroled in a social security plan
- •To have signed an informed consent
- •To have preliminary medical examination
- •For the groups :
- •"normal ECG" group : sinus rhythm without conductive troubles. Normal pattern of the QRS
- •"conductive troubles group" : patients with typical right bundle branch block, or typical left bundle branch block pattern.
- •"rhythm trouble group" : patients with premature atrial beats or premature ventricular beats
排除标准
- •Contraindication: implantable devices (cardiac stimulators, defibrillators, cochlear implants, etc.), metallic foreign bodies
- •Impossibility to undergo MRI: claustrophobia, morbid obesity.
- •Pregnancy or risk of pregnancy.
- •Patients under a measure of legal protection
结局指标
主要结局
Evaluation of the ECG signal quality
时间窗: One year
Evaluation of the ECG signal quality acquired in the MRI 3 Tesla by measuring the amplitude of the QRS complex (in millivolts). Conformity with IEC (International Electrotechnical Commission) 60601-2-51 standard.
次要结局
未报告次要终点
研究者
Dr Jean-Marc SELLAL
Cardiologist specialised in rhythmology
Central Hospital, Nancy, France