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

NCT07061821 | Recruiting

• 1 other identifier: PI2025_843_0122
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• LVEF Difference between both sequences

  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.

  day 1

Secondary Outcomes (6)

• 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

• 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

Interventions

accelerated cardiac cine-MRI sequence OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHRU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cédric Renard, MD

CONTACT

33+3 22 08 75 37; renard.cedric@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 11, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)