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

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05877755
Collaborator
Grant Agreement ERC SMHEART (Other)
200
1
1
60
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cardiac MRI acquisition
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging (CARDIO IRM)
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2028
Anticipated Study Completion Date :
Aug 31, 2028

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Imaging integration success [60 months]

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

Secondary Outcome Measures

  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) [60 months]

    Measure of training time and training loss function

  2. Cardiac MRI feature: location and size of myocardial scars/fibrosis [60 months]

    Measured in mL on late gadolinium enhancement images

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

    Measured in milliseconds

  4. CMR feature extracellular volume fraction (ECV) [60 months]

    Measured in mL/m2

  5. CMR feature ejection fraction [60 months]

    Measured in percentage

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu de Bordeaux Pessac France 33600

Sponsors and Collaborators

  • University Hospital, Bordeaux
  • Grant Agreement ERC SMHEART

Investigators

  • Principal Investigator: BUSTIN Aurelien, PHD, University Hospital, Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT05877755
Other Study ID Numbers:
  • CHUBX 2023/13
First Posted:
May 26, 2023
Last Update Posted:
May 26, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2023