Performance of Acquisition Automation of Cardiac MRI

NCT ID: NCT06012890

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-07-31

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.

Conditions

Workflow; Time

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Automatic acquisition

Clinical MRI planning performed automatically by an AI-based software

Automation of cardiac MRI acquisition

Intervention Type: OTHER

The intervention will consist of the automation of the cMRI examination.

Manual Acquisition

Clinical MRI planning performed manually by a specialized radiology technician

No interventions assigned to this group

Interventions

Automation of cardiac MRI acquisition

The intervention will consist of the automation of the cMRI examination.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Carl Glessgen

Medical Doctor, Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carl Glessgen, MD

Role: PRINCIPAL_INVESTIGATOR

Radiologist

Locations

University Hospital, Geneva

Geneva, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Carl Glessgen, MD

Role: CONTACT

carl.glessgen@hcuge.ch

00795536227

Other Identifiers

2023-01047

Identifier Type: -

Identifier Source: org_study_id