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临床试验/NCT05877755
NCT05877755招募中不适用

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

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Imaging integration success

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Imaging integration success

时间窗: 60 months

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

次要结局

  • CMR feature extracellular volume fraction (ECV)(60 months)
  • 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)
  • Cardiac MRI feature: location and size of myocardial scars/fibrosis(60 months)
  • Cardiac MRI feature native parameter values (T1, T2, T1-rho, T2*)(60 months)
  • CMR feature ejection fraction(60 months)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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