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Not Yet RecruitingNCT06617624

Magnetic Resonance Imaging Development for High Resolution Atrial Structural and Functional Characterization

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The main objective is to optimize the MRI protocol for the assessment of the LA in addition to a basic CMR protocol in order to define the best compromise between acquisition time and image quality (contrast between the different tissues, spatial and temporal resolutions, etc.) sufficient for accurate measurement of morphological, structural and hemodynamic left atrial biomarkers.

Detailed description

This Magnetic Resonance imaging study of the heart aims to acquire images and measures of: 1. Left atrial cine: compressed sensing cine imaging strategies will be tested for LA assessment by optimizing spatial and temporal resolution providing the best image quality relative to acceptable acquisition times. The whole heart should be covered during acquisition. Image quality and diagnosis of LA contraction preservation will be performed. 2. Myocardial tissue characterization including: 1. 3D isotropic ECG-gated with respiratory navigation late gadolinium enhancement (LGE) sequence for high resolution imaging of myocardial injury and fibrosis. 2. High resolution free-breathing T1/T2 mapping to quantify myocardial water content and measure native T1 relaxation and extracellular volume. 2D free breathing LGE will complement the protocol. 3. Cardiac adipose tissue imaging will be performed using gated Dixon imaging. Pericardial adipose tissue (PAT) will be measured covering the whole heart including groove epicardial adipose tissue (EAT). 3. Flow measurements: test and optimize a 4D flow approach for the heart and aorta using compressed sensing and multi velocity encoding (VENC) encoding to insure high and precise multi-chamber velocity imaging(100, 150, 200, 250 cm/s). Two-chamber (including left appendage) in plane velocities will be compared between high resolution 2D and 4D. Of, note, such multi-VENC approach is mandatory for LA imaging because of the large heterogeneity of blood flow velocities within the LA during the cardiac cycle. 4. Technology validation: comparison of cardiac triggering using the beat sensor vs. surface ECG-gating will be tested as a means of improving patient experience and speed up MRI acquisition for subsequent population imaging. This task will be performed at the Cardiovascular MRI Imaging Platform and Core Lab at the Pitié-Salpêtrière Hospital site by SU-ICAN \& APHP (ICT), SU-LIB and SIEMENS partners with the goal to optimize, test and validate innovative approaches before wider application.

Conditions

Interventions

TypeNameDescription
OTHERMRIHealthy volunteer will have a non-injected cardiovascular MRI
OTHERMRI ContrastPatients will have the gadolinium injected cardiovascular MRI

Timeline

Start date
2024-09-30
Primary completion
2026-10-30
Completion
2026-10-30
First posted
2024-09-27
Last updated
2024-09-27

Source: ClinicalTrials.gov record NCT06617624. Inclusion in this directory is not an endorsement.