Clinical trial NCT05877755: Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging
Official title: Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging (CARDIO IRM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Disease
Keywords: Cardiac MRI
Sequences
High-resolution
Multi-contrast
Imaging
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Grant Agreement ERC SMHEART
First posted: 2023-05-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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

Primary outcomes:
measure: Imaging integration success
timeFrame: 60 months
Secondary outcomes:
measure: 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)
timeFrame: 60 months
measure: Cardiac MRI feature: location and size of myocardial scars/fibrosis
timeFrame: 60 months
measure: Cardiac MRI feature native parameter values (T1, T2, T1-rho, T2*)
timeFrame: 60 months
measure: CMR feature extracellular volume fraction (ECV)
timeFrame: 60 months
measure: CMR feature ejection fraction
timeFrame: 60 months
Other outcomes:
Locations:
city: Pessac
country: France
facility: Chu de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: BUSTIN Aurelien, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bustin A, Stuber M, Sermesant M, Cochet H. Smart cardiac magnetic resonance delivering one-click and comprehensive assessment of cardiovascular disease. Eur Heart J. 2023 Feb 21;44(8):636-637. doi: 10.1093/eurheartj/ehac814. No abstract available.