Clinical trial NCT06012890: Performance of Acquisition Automation of Cardiac MRI
Official title: Impact of Acquisition Automation on the Duration and Quality of Cardiac MRI Examinations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Workflow
Time
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General population referred for morphological cardiac MRI, with consecutive patient sampling.

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.

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

Primary outcomes:
measure: Overall scan time
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital, Geneva
Study officials:
affiliation: Radiologist
name: Carl Glessgen, MD
role: PRINCIPAL_INVESTIGATOR
References: