Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging
Recruiting · NCT07455292 · Interventional (participants receive a specific treatment) · Lead sponsor: IRCCS Policlinico S. Donato
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study aims to enhance and streamline intracardiac 4D Flow magnetic resonance imaging (MRI) processing by increasing automation for the quantitative and systematic assessment of left ventricular (LV) dysfunction. The study is designed to achieve the following three objectives. The primary objective is to develop a convolutional neural network (CNN)-based deep learning model for the automatic segmentation of the LV endocardial contour throughout the cardiac cycle using intracavitary MRI data. To support model training, a dataset of LV endocardial wall segmentations will be generated from balanced steady-state free precession (bSSFP) images. A purpose-built retrospective MRI database of bSSFP images will be retrieved to accelerate training set creation. The secondary objective is to develop a numerical framework for non-invasive MRI-based pressure-volume (PV) loop reconstruction and calculation of simplified hemodynamic force descriptors (HDFs). A prospective cohort of patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) will be enrolled. Pre-procedural non-contrast 4D Flow MRI will be acquired, and non-invasive MRI-derived PV loops will be quantitatively compared with invasive catheter-based PV loop measurements. In addition, simplified HDFs will be compared with 4D Flow-derived HDFs to assess their agreement and their potential to elucidate specific features of heart failure-related LV dysfunction. The tertiary objective is to establish the foundation for a unified, standalone, and clinically deployable framework for comprehensive, automated, and clinician-friendly analysis of LV hemodynamics based on 4D Flow MRI. Internal testing, benchmarking, and structured evaluation by clinical end-users with prior 4D Flow MRI research experience will be conducted to collect feedback and guide further development and clinical translation.
Who can take part
Inclusion criteria
- Adult patients (age \> 18 years old);
- Diagnosis of severe AS defined according to ESC guidelines with indication to TAVR;
- Severe aortic stenosis both in normal/high flow status and in low flow status;
- Signed informed written consent.
Exclusion criteria
- Contraindication to cardiac MRI due to previous implant with ferromagnetic components;
- Poor MRI quality impairing image post-processing;
- Claustrophobia;
- Unwilling to sign the informed consent.
Where it is running
2 locations listed.
- IRCCS Policlinico San Donato - San Donato Milanese, Italy
- IRCCS Policlinico San Donato - San Donato Milanese, Italy