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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Disease
• Intervention / Treatment: Device: Cardiac MRI acquisition

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).

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BUSTIN Aurelien, PHD; Phone Number: +33 6 16 29 05 91; Email: aurelien.bustin@ihu-liryc.fr
• Study Contact Backup: Name: COCHET Hubert, MD, PHD; Phone Number: +33 5 57 65 65 42; Email: hubert.cochet@chu-bordeaux.fr

Study Locations

• France
  • Pessac, France, 33600
    • CHU de Bordeaux
    • Contact: BUSTIN Aurelien, PHD; Phone Number: +33 6 16 29 05 91; Email: aurelien.bustin@ihu-liryc.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Cardiac MRI acquisition; 200 patients with a clinical indication for cardiac magnetic resonance imaging

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging integration success	Measure of image quality according to signal-to-noise ratio	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cardiac MRI feature: location and size of myocardial scars/fibrosis	Measured in mL on late gadolinium enhancement images	60 months
Cardiac MRI feature native parameter values (T1, T2, T1-rho, T2*)	Measured in milliseconds	60 months
CMR feature extracellular volume fraction (ECV)	Measured in mL/m2	60 months
CMR feature ejection fraction	Measured in percentage	60 months

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Grant Agreement ERC SMHEART
• Investigators: Principal Investigator: BUSTIN Aurelien, PHD, University Hospital, Bordeaux

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Imaging; Cardiac MRI; Sequences; High-resolution; Multi-contrast
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: CHUBX 2023/13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No