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

Not Applicable
Recruiting
Conditions
Cardiac Disease
Interventions
Device: Cardiac MRI acquisition
Registration Number
NCT05877755
Lead Sponsor
University Hospital, Bordeaux
Brief Summary

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.

Detailed Description

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 this project 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.

This aim will be achieved by (i) creating a novel imaging technology that collects CMR data in a single continuous free-breathing scan, taking into account post-processing requirements at the very origin of CMR sequence design; (ii) exploiting the unique contrasts generated by this technology to automatically extract quantitative markers on cardiac anatomy, function, and tissue characteristics; and (iii) translating this transformative technology to a clinical setting.

This will be the first-ever integrated cardiac imaging pipeline in which CMR images are acquired in a single click, jointly represented in a single volume, and automatically analysed. This will unlock obstacles for broader acceptance of CMR and unleash the full potential of CMR to maximize its impact on patient trajectories. The results of this project will pave the way towards robust image-based strategies for personalized patient care (diagnosis, risk stratification, therapy selection, monitoring, and image-guided interventions).

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
200
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Cardiac MRI acquisitionCardiac MRI acquisition200 patients with a clinical indication for cardiac magnetic resonance imaging
Primary Outcome Measures
NameTimeMethod
Imaging integration success60 months

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

Secondary Outcome Measures
NameTimeMethod
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)60 months

Measure of training time and training loss function

Cardiac MRI feature: location and size of myocardial scars/fibrosis60 months

Measured in mL on late gadolinium enhancement images

Cardiac MRI feature native parameter values (T1, T2, T1-rho, T2*)60 months

Measured in milliseconds

CMR feature ejection fraction60 months

Measured in percentage

CMR feature extracellular volume fraction (ECV)60 months

Measured in mL/m2

Trial Locations

Locations (1)

Chu de Bordeaux

🇫🇷

Pessac, France

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