Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06012890
Status:
RECRUITING
Last Update Posted:
2023-08-28
First Post:
2023-08-14
Brief Title:
Performance of Acquisition Automation of Cardiac MRI
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Impact of Acquisition Automation on the Duration and Quality of Cardiac MRI Examinations
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 studys 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None