- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05105984
Evaluation of a Free-breathing Cardiac Cine-MRI Sequence With Image Reconstructions by Deep-Learning in Ischemic Heart Disease (CINEDL)
Evaluation of a Free-breathing Cardiac Cine-MRI Sequence With Image Reconstructions Developed by Deep-Learning Compared to the Classic Apnea Cine-MRI Sequence in the Assessment of Ischemic Heart Disease.
Today, MRI is the gold standard for the precise assessment of left ventricular volume and function, but presents the drawback of having a long acquisition time and of generating motion artifacts, in particular respiratory artifacts, requiring repeated sequences in apnea to cover the whole cardiac volume. These apneas are difficult to achieve in patients with ischemic heart disease and may lead to degradation of the images, an increase in the duration of the examination by repeated acquisitions and therefore to diagnostic inaccuracies.
Artificial intelligence, already used in practice in cardiac MRI for automatic segmentation of the heart chambers, improves radiological interpretation with rapid and precise measurements. Deep-learning, which is part of artificial intelligence, would allow the reconstruction of cine-MRI sequences in free breathing, in order to overcome the artifacts from respiratory motions, and the improvement of diagnostic performance while improving examination conditions for patients.
Patients coming for a cardiac MRI for the assessment of ischemic heart disease will be eligible to the protocol. If the patient agrees to participate, a free-breathing cardiac cine-MRI sequence with Deep Learning based image reconstruction will be added to the usual protocol.
No follow-up will be required in this study.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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France
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Amiens, France, France, 80000
- CHU Amiens-Picardie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Cardiac MRI is one of the examinations prescribed as part of routine care for this pathology. When the patient come for a cardiac MRI in the workup for ischemic heart disease, the patient will be asked on the day of the exam if he agrees to participate in the study. An information letter will have been sent to the patient before the appointment is made.
In the event that he agrees to participate, a free-breathing cardiac cine-MRI sequence with Deep Learning based image reconstruction will be appended to the usual protocol.
Description
Inclusion Criteria:
- Age > or = 18 years old
- Ischemic heart disease
- Ability of the subject to understand and express his consent
- Affiliation to the social security scheme
Exclusion Criteria:
- Major obesity (> 140kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70cm
- Under 18 years old
- Pregnant woman
- Known allergy to gadolinium chelates
- Claustrophobia
- Any contraindication to MRI
- Arrhythmia
- Difficulty in holding apneas of more than 10 seconds
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
difference of LVEF measurements between Deep Learning reconstruction and the classic cine-MRI sequence
Time Frame: 5 minutes
|
difference of LVEF measurements between Deep Learning reconstruction and the classic cine-MRI sequence
|
5 minutes
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2021_843_0157
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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