Performance of Acquisition Automation of Cardiac MRI

Time Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06012890
• Other study ID #: 2023-01047
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: August 2023
• Source: University Hospital, Geneva
• Contact: Carl Glessgen, MD
• Phone: 00795536227
• Email: carl.glessgen[@]hcuge.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Time
• Workflow

Intervention

Other:
• Automation of cardiac MRI acquisition
The intervention will consist of the automation of the cMRI examination.

Locations

Country	Name	City	State
Switzerland	University Hospital, Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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