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

Cardiac Disease Clinical Trial

— CARDIO-IRM  

Official title:

Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging (CARDIO IRM)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05877755
• Other study ID #: CHUBX 2023/13
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 31, 2028

Study information

• Verified date: May 2023
• Source: University Hospital, Bordeaux
• Contact: BUSTIN Aurelien, PHD
• Phone: +33 6 16 29 05 91
• Email: aurelien.bustin[@]ihu-liryc.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Device:
• Cardiac MRI acquisition
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.

Locations

Country	Name	City	State
France	Chu de Bordeaux	Pessac

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Grant Agreement ERC SMHEART

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging integration success	Measure of image quality according to signal-to-noise ratio	60 months
Secondary	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	60 months
Secondary	Cardiac MRI feature: location and size of myocardial scars/fibrosis	Measured in mL on late gadolinium enhancement images	60 months
Secondary	Cardiac MRI feature native parameter values (T1, T2, T1-rho, T2*)	Measured in milliseconds	60 months
Secondary	CMR feature extracellular volume fraction (ECV)	Measured in mL/m2	60 months
Secondary	CMR feature ejection fraction	Measured in percentage	60 months