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临床试验/NCT06855238
NCT06855238已完成不适用

Clinical Validation of an Artificial Intelligence Tool to Predict Inversion Time

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Images quality proportion

研究概览

简要总结

Introduction: Inversion-recovery (IR) magnetic resonance (MR) sequences are commonly used to perform late-gadolinium enhancement (LGE) imaging during cardiac magnetic resonance (CMR) scans. Inversion Time (TI), i.e. the time between the 180° inverting pulse and the 90°-pulse, must be manually input to obtain optimal myocardium nulling. Determinants of this value are patient's, sequence, and contrast characteristics, and the time after contrast injection. The identification of the correct TI is pivotal to quality images. The determination of TI is mostly based on experience, and it can be challenging in some diseases and for less experienced operators.

Aim of this study is to test in a clinical setting an Artificial Intelligence (AI) tool, which we developed to automatically predict TI in CMR post-contrast IR LGE sequences, named "THAITI".

THAITI performance will be evaluated in terms of 1) quality of images obtained using the AI-predicted TI with a 4-point Likert scale; 2) quality of images obtained using the AI-predicted TI in terms of Contrast-Enhancement ratio, i.e. the signal intensity of enhanced/remote myocardium in CMR-LGE images; 3) numbers of images that need to be reacquired; 4) average time duration of CMR-LGE imaging.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients in whom CMR-LGE is performed for a clinical reason
  • •Mixed cardiac conditions (including cardiomyopathies, ischemic heart disease, normal scans, focal and diffuse myocardial pathological processes)
  • •Both sexes
  • •Availability of serum creatinine, measured within one month prior to CMR
  • •Provision of the written informed consent

排除标准

  • •Non-contrast CMR
  • •First-pass perfusion stress-CMR
  • •Absolute contraindication to CMR
  • •Inadequate overall image quality

研究组 & 干预措施

Operator-set TI (control group)

No Intervention

During the cardiovascular magnetic resonance scan, the TI is set by an experienced human operator as per standard clinical practice

THAITI-set TI

Experimental

During the cardiovascular magnetic resonance scan, the TI is set by the experimental software

干预措施: THAITI software (Device)

结局指标

主要结局

Images quality proportion

时间窗: At examination

Proportion of images with optimal/good quality

次要结局

  • contrast-enhancement ratio(At examination)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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