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

Not Applicable

Not yet recruiting

• Conditions: Left Ventricular Ejection Fraction; Cardiac Magnetic Resonance Imaging; Deep Learning; Image Reconstruction; Left Ventricular Hypertrophy

• Registration Number: NCT07061821
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-01
• Study First Posted: 2025-07-11
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18
• Study Start: 2025-09-01
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
LVEF Difference between both sequences	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.

Secondary Outcome Measures

Name	Time	Method
difference of end-diastolic volume of the left ventricle between both sequences	day 1	Value of the difference between the measurements of end-diastolic volumes of the left ventricle obtained using the accelerated cardiac cine-MRI sequence with Deep Learning-based image reconstruction compared to the conventional cine-MRI sequence.
difference of end-systolic volume of the left ventricle between both sequences	day 1	Value of the difference between the measurements of end-systolic volumes of the left ventricle obtained using the accelerated cardiac cine-MRI sequence with Deep Learning-based image reconstruction compared to the conventional cine-MRI sequence.
Difference of the acquisition time between both sequences	day 1	Value of the difference in acquisition time between the accelerated cardiac cine-MRI sequence with Deep Learning-based image reconstruction and the conventional cine-MRI sequence
Differnce of measurement of the global longitudinal strain of the left ventricle between both sequences	day 1	Value of the difference between the measurement of global longitudinal strain of the left ventricle obtained using the accelerated cardiac cine-MRI sequence with Deep Learning-based image reconstruction compared to the conventional cine-MRI sequence.
Difference of the left ventricular mass between both sequences	day 1	Value of the difference between the measurement of left ventricular mass obtained using the accelerated cardiac cine-MRI sequence with Deep Learning-based image reconstruction compared to the conventional cine-MRI sequence.
diffrence of the maximal thickness of the left ventricle between both sequences	day 1	Value of the difference between the measurement of maximal thickness of the left ventricle obtained using the accelerated cardiac cine-MRI sequence with Deep Learning-based image reconstruction compared to the conventional cine-MRI sequence.

Trial Locations

Locations (1)

CHRU Amiens; 🇫🇷 Amiens, France