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

NCT ID: NCT07061821

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-05

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cédric Renard, MD

Role: CONTACT

33+3 22 08 75 37

Facility Contacts

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Cedric Renard, MD

Role: primary

33+3 22 08 75 37

Other Identifiers

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PI2025_843_0122

Identifier Type: -

Identifier Source: org_study_id

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