Evaluation of Left Ventricular Ejection Fraction Using an Accelerated Cardiac Cine-MRI Sequence With Deep Learning-based Image Reconstructions Compared to the Reference Cine-MRI Sequence in the Assessment or Follow-up of Left Ventricular Hypertrophy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- LVEF Difference between both sequences
研究概览
简要总结
Left ventricular hypertrophy (LVH) is a common condition that may result from hypertension, hypertrophic cardiomyopathy, aortic valve stenosis, or certain metabolic disorders. Cardiac imaging is essential for diagnosis, prognostic assessment, and quantification of cardiac function. While transthoracic echocardiography remains widely used, it is limited by acoustic window dependence and inter-observer variability. Cardiovascular Magnetic Resonance (CMR) imaging currently serves as the reference standard for measuring left ventricular ejection fraction (LVEF), cardiac volumes, and tissue characterization. However, conventional cine-CMR sequences require repeated breath-holds, which are often challenging for elderly or dyspneic patients, generating respiratory motion artifacts that compromise image quality. Accelerated cine-CMR sequences with deep learning-based image reconstructions offer a promising alternative by significantly reducing acquisition time while preserving image quality. This study aims to evaluate whether these accelerated cine-CMR sequences provide LVEF measurements concordant with conventional cine-CMR sequences, with potential to improve patient comfort and reduce examination time.
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
- 否
入选标准
- •Patient referred for cardiac MRI as part of the assessment or follow-up of left ventricular hypertrophy
- •Age ≥ 18 years old
- •Ability of the subject to understand and express his consent
- •Affiliation to the social security scheme
排除标准
- •Severe obesity (>140 kg) preventing the patient from entering the scanner bore, which has a diameter of less than 70 cm
- •Age ≥ 18 years old
- •Person under guardianship or curators, or deprived of liberty
- •Pregnant or breastfeeding woman
- •Known allergy to gadolinium chelates
- •Claustrophobia
- •Any contraindication to MRI
- •Arrhythmia
- •Inability to hold breath for more than 10 seconds
结局指标
主要结局
LVEF Difference between both sequences
时间窗: day 1
Value of the difference between the measurement of left ventricular ejection fraction (LVEF) obtained using the accelerated cardiac cine-MRI sequence with Deep Learning-based image reconstruction compared to the conventional cine-MRI sequence.
次要结局
- Differnce of measurement of the global longitudinal strain of the left ventricle between both sequences(day 1)
- diffrence of the maximal thickness of the left ventricle between both sequences(day 1)
- Difference of the acquisition time between both sequences(day 1)
- difference of end-diastolic volume of the left ventricle between both sequences(day 1)
- difference of end-systolic volume of the left ventricle between both sequences(day 1)
- Difference of the acquisition time between both sequences(day 1)
- Differnce of measurement of the global longitudinal strain of the left ventricle between both sequences(day 1)
- Difference of the left ventricular mass between both sequences(day 1)
- diffrence of the maximal thickness of the left ventricle between both sequences(day 1)
