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Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging

ConditionCardiac Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

Cardiovascular disease (CVD) causes at least 1.8 million European deaths annually, exceeding fatalities from cancer, chronic respiratory disease, and diabetes. Consequently, the fight against CVD has become the main priority of the World Health Organization. In the pursuit of understanding and treating CVD, cardiac magnetic resonance imaging (CMR) has remained the only modality capable of providing a comprehensive assessment of the heart's function and structure without harmful radiation. Unfortunately, current CMR systems remain too slow, too complex, require highly trained specialists and, as such, have presented a barrier to a wider adoption of CMR. The aim of CARDIO-IRM is to unleash the full potential of CMR to transform patient trajectories by introducing a fast, one-click, fully automated, and comprehensive imaging pipeline applicable to diagnosis, prognosis, and therapy selection in cardiology.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult patient (over 18 years of age) requiring an MRI scan as part of their care.

Male or female.

Affiliated or beneficiary of a social security scheme

Having given his/her oral no objection after having read the information note

Disqualifiers

Patient unable to give oral consent (guardianship, non-French speaker, etc.)

Patient deprived of liberty

Patient who does not meet the specific eligibility criteria for an MRI examination: pregnant women, known pathology that may interfere with acquisition (e.g. Parkinson's disease), absolute or relative contraindication to an MRI examination

Patient participating in a therapeutic interventional trial or in a period of relative exclusion in relation to another protocol

Trial design

Design model

Single group

Treatments tested in this trial

  • Cardiac MRI acquisition

    Device

    All patients will have additional images collected during the magnetic resonance imaging (MRI) examination. These are high-resolution multi-contrast cardiac MRI sequences in gradient echo or in balanced steady state free precession with synchronization on the electrocardiogram. The acquisitions last between 1 minute and 10 minutes. This duration depends on the patient's heart rate and breathing rate. The imaging protocol will last approximately 50 minutes. MRI examinations will be performed on a 1.5 Tesla clinical system with specific cardiac imaging coils.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Cardiac MRI acquisitionOther 1 intervention

Trial outcomes

Primary outcomes

1

Imaging integration success

Measure of image quality according to signal-to-noise ratio

Time frame
60 months

Secondary outcomes

1

Integration of the collected images in an internal database to develop new reconstruction and image processing algorithms specific to this application (e.g. using artificial intelligence)

Measure of training time and training loss function

Time frame
60 months
2

Cardiac MRI feature: location and size of myocardial scars/fibrosis

Measured in mL on late gadolinium enhancement images

Time frame
60 months
3

Cardiac MRI feature native parameter values (T1, T2, T1-rho, T2*)

Measured in milliseconds

Time frame
60 months
4

CMR feature extracellular volume fraction (ECV)

Measured in mL/m2

Time frame
60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

Grant Agreement ERC SMHEART

Collaborator

Source ClinicalTrials.gov
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