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NCT Number: NCT05877755

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Bordeaux

Pessac, 33600, France

Location status: Recruiting

Location contact

BUSTIN Aurelien, PHD

CONTACT

[email protected]

+33 6 16 29 05 91

Hubert COCHET

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac MRI acquisition

Device

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.

Primary outcomes

  1. Imaging integration success

    Time frame: 60 months

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

Secondary outcomes

  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)

    Time frame: 60 months

    Measure of training time and training loss function

  2. Cardiac MRI feature: location and size of myocardial scars/fibrosis

    Time frame: 60 months

    Measured in mL on late gadolinium enhancement images

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

    Time frame: 60 months

    Measured in milliseconds

  4. CMR feature extracellular volume fraction (ECV)

    Time frame: 60 months

    Measured in mL/m2

  5. CMR feature ejection fraction

    Time frame: 60 months

    Measured in percentage

Study contacts

Contact information is provided by the study sponsor or research team.

BUSTIN Aurelien, PHD

CONTACT

[email protected]

+33 6 16 29 05 91

COCHET Hubert, MD, PHD

CONTACT

[email protected]

+33 5 57 65 65 42

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Grant Agreement ERC SMHEART

Registry information

Official study title

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

Acronym: CARDIO-IRM

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
May 26, 2023
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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