跳至主要内容
临床试验/NCT07061821
NCT07061821招募中不适用

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

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2025年8月5日最近更新:
适应症

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验