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
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Condition or disease | Intervention/treatment |
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Workflow Time | Other: Automation of cardiac MRI acquisition |
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 |
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 |
Group/Cohort | Intervention/treatment |
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Automatic acquisition
Clinical MRI planning performed automatically by an AI-based software
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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
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- 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.
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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 |
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
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
Contact: Carl Glessgen, MD | 00795536227 | carl.glessgen@hcuge.ch |
Switzerland | |
University Hospital, Geneva | Recruiting |
Geneva, Switzerland |
Principal Investigator: | Carl Glessgen, MD | Radiologist |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |