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Recruiting NCT07061821

Evaluation of Left Ventricular Ejection Fraction Using an Accelerated Cardiac Cine-MRI Sequence With Deep Learning-based Image Reconstructions

No phase Interventional Left Ventricular Ejection Fraction Cardiac Magnetic Resonance Imaging Deep Learning Image Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: accelerated cardiac cine-MRI sequence.
Who it may be relevant to
Registry conditions: Left Ventricular Ejection Fraction, Cardiac Magnetic Resonance Imaging, Deep Learning, Image Reconstruction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other accelerated cardiac cine-MRI sequence
    Addition of an accelerated cardiac cine-MRI sequence with deep learning-based image reconstruction to the standard cardiac MRI protocol, performed during the same session

Primary outcome measures

  • LVEF Difference between both sequences [Time frame: day 1]
Secondary outcome measures (6)
  • difference of end-diastolic volume of the left ventricle between both sequences [Time frame: day 1]
  • difference of end-systolic volume of the left ventricle between both sequences [Time frame: day 1]
  • Differnce of measurement of the global longitudinal strain of the left ventricle between both sequences [Time frame: day 1]
  • Difference of the left ventricular mass between both sequences [Time frame: day 1]
  • diffrence of the maximal thickness of the left ventricle between both sequences [Time frame: day 1]
  • Difference of the acquisition time between both sequences [Time frame: day 1]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHRU Amiens — Amiens

Identifiers

NCT: NCT07061821 · PI2025_843_0122

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗