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Performance of Acquisition Automation of Cardiac MRI

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ClinicalTrials.gov Identifier: NCT06012890
Recruitment Status : Recruiting
First Posted : August 28, 2023
Last Update Posted : August 28, 2023
Sponsor:
Information provided by (Responsible Party):
Carl Glessgen, University Hospital, Geneva

Study Description
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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.

Condition or disease Intervention/treatment
Workflow Time Other: Automation of cardiac MRI acquisition

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 Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Acquisition Automation on the Duration and Quality of Cardiac MRI Examinations
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
Automatic acquisition
Clinical MRI planning performed automatically by an AI-based software
 Other: Automation of cardiac MRI acquisition
The intervention will consist of the automation of the cMRI examination.
Manual Acquisition
Clinical MRI planning performed manually by a specialized radiology technician


Outcome Measures
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Primary Outcome Measures :
  1. Overall scan time [ Time Frame: Up to 12 months ]
    This study's primary endpoint will be the overall scan time, from first to last MRI image acquired.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
General population referred for morphological cardiac MRI, with consecutive patient sampling.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06012890


Contacts
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Contact: Carl Glessgen, MD 00795536227 carl.glessgen@hcuge.ch

Locations
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Switzerland
University Hospital, Geneva Recruiting
Geneva, Switzerland
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Carl Glessgen, MD Radiologist
More Information
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Responsible Party: Carl Glessgen, Medical Doctor, Consultant, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT06012890    
Other Study ID Numbers: 2023-01047
First Posted: August 28, 2023    Key Record Dates
Last Update Posted: August 28, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No