WorkflowNCT06012890
Performance of Acquisition Automation of Cardiac MRI
An observational study of Workflow and Time, run by University Hospital, Geneva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Automation of cardiac MRI acquisition
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population referred for morphological cardiac MRI, with consecutive patient sampling.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital, Geneva
Geneva
About this study
Official title: 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.
Read the 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.
- Being tested
- Automation of cardiac MRI acquisition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automation of cardiac MRI acquisitionOther
The intervention will consist of the automation of the cMRI examination.
| Study group | Role | What they receive |
|---|---|---|
| Automatic acquisition | Clinical MRI planning performed automatically by an AI-based software Receives: Other: Automation of cardiac MRI acquisition | |
| Manual Acquisition | Clinical MRI planning performed manually by a specialized radiology technician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall scan time
This study's primary endpoint will be the overall scan time, from first to last MRI image acquired.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Aug 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WorkflowStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl Glessgen, University Hospital, Geneva
- Investigators
- Carl Glessgen, MD, Principal investigator, Radiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012890
- Sponsor's protocol ID
- 2023-01047
- Other IDs
- 2023
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acquisition Automation on the Duration and Quality of Cardiac MRI Examinations
- ClinicalTrials.gov ID
- NCT06012890
- Acronym / sponsor ID
- 2023-01047
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automatic acquisition | – | Other: Automation of cardiac MRI acquisitionClinical MRI planning performed automatically by an AI-based software |
| Manual Acquisition | – | –Clinical MRI planning performed manually by a specialized radiology technician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population referred for morphological cardiac MRI, with consecutive patient sampling.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automation of cardiac MRI acquisitionThe intervention will consist of the automation of the cMRI examination. | Other | Automatic acquisition |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Glessgen, MD principal investigator
Radiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Workflow and Time, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carl Glessgen, MD (00795536227, carl.glessgen@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall scan time (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.