Impact of Acquisition Automation on the Duration and Quality of Cardiac MRI Examinations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Overall scan time
研究概览
简要总结
For this study, cardiac MRI examinations performed will be prospectively included and realized either fully automatically or by a specialized radiology technician. The duration of the automated examinations will be compared to the duration of the manual examinations. The number of failed sequences in both study arms (automated and manual) will be recorded and the quality of the cardiac planes will be compared.
详细描述
The main hypothesis is that fully automated cardiac MRI protocols require shorter overall scan times than manually acquired, human-executed protocols. The objective will be to demonstrate that automating the examination allows to shorten the scan time, leading to increased patient comfort and clinical flexibility. The study's secondary objective will be to demonstrate the non-inferiority of the automated protocol compared to human acquisition in terms of resulting planning quality and error occurrence during slice planning.
Included patients will undergo clinical cMRI following international and national standards: only the acquisition strategy will vary. The investigators will successively recruit patients presenting for routine cardiac MRI. The acquisition strategy of the MRI - either automated or manual - will alternate to avoid comparison bias.
The MRI protocol will be the same for both arms and consists of standardized sequences acquired before and after contrast administration. Recruitment will be performed at a single location, in the radiology department. Patients will be recruited on a daily, consecutive basis during clinical practice.
No questionnaire will be used for this study. No biological material will be sampled. Observational data about the acquisition process, potential errors, and patient characteristics will be recorded.
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
- 是
入选标准
- •Adult patient presenting for morphologic and functional assessment of the myocardium by cardiac MRI.
- •Research consent form obtained after information procedure.
- •Complete cardiac MRI protocol performed.
排除标准
- •Patients unable to provide informed consent.
- •Implantable cardiac device
- •Incomplete cardiac examination due to early termination by the patient.
- •Incomplete data on examination parameters (missing forms).
- •Incompatible MRI protocol
结局指标
主要结局
Overall scan time
时间窗: Up to 12 months
This study's primary endpoint will be the overall scan time, from first to last MRI image acquired.
次要结局
未报告次要终点
研究者
Carl Glessgen
Medical Doctor, Consultant
University Hospital, Geneva
