MRI
OtherHealthy volunteer will have a non-injected cardiovascular MRI
NCT Number: NCT06617624
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
This Magnetic Resonance imaging study of the heart aims to acquire images and measures of:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For all groups of AF patients:
Specific inclusion criteria of AF patients (same as MAESTRIA-AFNET 10) Group 1: patients with paroxysmal AF (no AF during exam) clinically defined as AF episodes less than one week Group 2: patients with persistent AF, clinically defined as AF episodes longer than one week Group 3: patients with permanent AF, with no documented sinus rhythm or possibility to restore sinus rhythm by any means
For healthy volunteers (Group 4):
Exclusion criteria
For all groups
Healthy volunteer will have a non-injected cardiovascular MRI
Patients will have the gadolinium injected cardiovascular MRI
Time frame: 24 months
Measurement of maximal Left Atrial (LA) longitudinal strain. Comparison between patients and healthy volunteers will allow to define normal values and thresholds for the given sequences.
Time frame: 24 months
The metrics from the Linear regression and Bland and Altman analyses will be used to compare the various calibration settings against reference.
Time frame: 24 months
The correlation coefficients from the linear regressions will be estimated to assess the associations mentioned in the secondary objectives between the new biomarkers and the more established biomarkers.
Time frame: 24 months
The correlation coefficients from the linear regressions will be estimated to assess the associations mentioned in the secondary objectives between the new biomarkers and the more established biomarkers.Between LA imaging biomarkers and subcutaneous aging and pressure levels
Time frame: 24 months
Metric of ROC analysis
Time frame: 24 months
The intra-operator coefficient of variation.
Time frame: 24 months
The inter-operator coefficient of variation.
Contact information is provided by the study sponsor or research team.
Alban Redheuil, MD, PhD
CONTACT
+33142165545 ext. +33
Nadjia KACHENOURA, PhD
CONTACT
+33144279116 ext. +33
Assistance Publique - Hôpitaux de Paris
Other
Acronym: MRI-HiRA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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