Performance of Acquisition Automation of Cardiac MRI

Impact of Acquisition Automation on the Duration and Quality of Cardiac MRI Examinations

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.

Study Overview

• Status: Recruiting
• Conditions: Time; Workflow
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Carl Glessgen, MD; Phone Number: 00795536227; Email: carl.glessgen@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland
    • Recruiting
    • University Hospital, Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

General population referred for morphological cardiac MRI, with consecutive patient sampling.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Carl Glessgen, MD, Radiologist

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023-01047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No