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Performance of Acquisition Automation of Cardiac MRI

University Hospitals (UH) logo

University Hospitals (UH)

Status

Enrolling

Conditions

Time
Workflow

Treatments

Other: Automation of cardiac MRI acquisition

Study type

Observational

Funder types

Other

Identifiers

NCT06012890
2023-01047

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Automatic acquisition
Description:
Clinical MRI planning performed automatically by an AI-based software
Treatment:
Other: Automation of cardiac MRI acquisition
Manual Acquisition
Description:
Clinical MRI planning performed manually by a specialized radiology technician

Trial contacts and locations

1

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Central trial contact

Carl Glessgen, MD

Data sourced from clinicaltrials.gov

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