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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01951-44 | Other Identifier | ID-RCB |
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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.
This Magnetic Resonance imaging study of the heart aims to acquire images and measures of:
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.
Myocardial tissue characterization including:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: patient with paroxysmal AF (Atrial Fibrillation) (no AF during exam) | 20 patients able to complete the full standard experimental examination corresponding to paroxysmal AF group |
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| Group 2: patient with persistent AF (Atrial Fibrillation) | 20 patients able to complete the full standard experimental examination corresponding to persistent AF group |
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| Group 3: patient with permanent AF (Atrial Fibrillation) | 20 patients able to complete the full standard experimental examination corresponding to permanent AF group |
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| Group 4: healthy volunteer | 60 age/sex BMI class matched healthy volunteers, able to complete the full standard experimental examination. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Other | Healthy volunteer will have a non-injected cardiovascular MRI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of maximal Left Atrial (LA) longitudinal strain | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Various calibration settings against reference. | The metrics from the Linear regression and Bland and Altman analyses will be used to compare the various calibration settings against reference. | 24 months |
| The correlation coefficients from the linear regressions |
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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
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3 groups of patients and 1 control group: paroxysmal AF (atrial fibrillation) (no AF during exam), persistent AF, permanent AF and healthy controls.
20 patients able to complete the full standard experimental examination corresponding to each AF group and 60 age/sex BMI class matched healthy volunteers, able to complete the full standard experimental examination.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alban Redheuil, MD, PhD | Contact | +33142165545 | +33 | alban.redheuil@aphp.fr |
| Nadjia KACHENOURA, PhD | Contact | +33144279116 | +33 | nadjia.kachenoura@inserm.fr |
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Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| MRI Contrast |
| Other |
Patients will have the gadolinium injected cardiovascular MRI |
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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. |
| 24 months |
| The correlation coefficients from the linear regressions | 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 | 24 months |
| ROC analysis | Metric of ROC analysis | 24 months |
| The intra-operator coefficient of variation. | The intra-operator coefficient of variation. | 24 months |
| The inter-operator coefficient of variation. | The inter-operator coefficient of variation. | 24 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |