Performance of Acquisition Automation of Cardiac MRI

Recruiting

• Conditions: Time; Workflow
• Interventions: Other: Automation of cardiac MRI acquisition

• Registration Number: NCT06012890
• Lead Sponsor: University Hospital, Geneva

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 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.

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08-01
• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-21
• Last Update Submitted: 2023-08-21
• Study First Posted: 2023-08-28
• Last Update Posted: 2023-08-28
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Automatic acquisition	Automation of cardiac MRI acquisition	Clinical MRI planning performed automatically by an AI-based software

Primary Outcome Measures

Name	Time	Method
Overall scan time	Up to 12 months	This study's primary endpoint will be the overall scan time, from first to last MRI image acquired.

Trial Locations

Locations (1)

University Hospital, Geneva; 🇨🇭 Geneva, Switzerland