Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617624
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Magnetic Resonance Imaging Development for High Resolution Atrial Structural and Functional Characterization
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Magnetic Resonance Imaging Development for High Resolution Atrial Structural and Functional Characterization
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MRI-HiRA
Brief 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 T1T2 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 imaging100 150 200 250 cms 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
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 T1T2 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 imaging100 150 200 250 cms 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None