Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05284058
Status:
RECRUITING
Last Update Posted:
2023-08-04
First Post:
2022-02-25
Brief Title:
Impact of Preoperative Myocardial Fibrosis Related to Mitral Valve Prolapse on Postoperative Left Ventricular Remodeling
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Impact of Preoperative Myocardial Fibrosis Related to Mitral Valve Prolapse on Postoperative Left Ventricular Remodeling
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPARED
Brief Summary:
Primary mitral regurgitation MR is the most common valvular disease in western countries The MR mechanism is often related to a mitral valve prolapse MVP defined as a single or bi-leaflet prolapse of at least 2 mm beyond the long-axis mitral annular plane
In recent years several studies have identified a subtype of MVP patients at higher risk of ventricular arrhythmias VA and sudden cardiac death SCD The presence of regional myocardial replacement fibrosis RMRF has been shown as a risk marker of arrhythmic events VA and SCD in patients with MVP RMRF can be identified using cardiac magnetic resonance CMR imaging with late gadolinium enhancement LGE In these patients fibrosis was found in the basal inferolateral myocardium and at the level of papillary muscles PMs This fibrosis is developed beyond the volume overload related to the MVP It is probably linked to the mechanical stretch acting upon the valve and the neighboring left ventricle LV myocardium RMRF is associated with a high degree of MR with specific features of mitral valve apparatus bi-leaflet prolapse with marked leaflet redundancy mitral annulus abnormalities ie Mitral-Annular Disjunction and more dilated LV It is also independently associated with the occurrence of cardiovascular events
Mitral valve repair MVr is the gold standard treatment for primary Mitral Regurgitation Very little data concerning the impact of preoperative RMRF on mitral valve surgery outcomes is available and the impact of myocardial fibrosis on the postoperative left ventricle remodeling has not been studied so far
No previous study compares preoperative and postoperative fibrosis evolution Thus no data exists regarding the postoperative evolution of this fibrosis and its relationship with ventricular arrhythmic risk after valve surgery Small observational studies have suggested that mitral valve surgery did not reduce the risk of ventricular arrhythmias in patients with bileaflet MVP
Finally the mechanisms involved in the development of regional myocardial replacement fibrosis within the left ventricle myocardium during the natural history of MVP cannot be understood with current standard medical imaging tools Numerical simulation technologies provide an innovative and in-vivo approach to assess the physical and pathological mechanisms causing this fibrosis They can also be used to assess the changes in mitral valve and myocardium dynamics after surgical mitral valve repair procedures
A large consortium involving physicians and scientists has been created to address these questions to fulfil our objectives over a 4 year period SIMR project
In recent years several studies have identified a subtype of MVP patients at higher risk of ventricular arrhythmias VA and sudden cardiac death SCD The presence of regional myocardial replacement fibrosis RMRF has been shown as a risk marker of arrhythmic events VA and SCD in patients with MVP RMRF can be identified using cardiac magnetic resonance CMR imaging with late gadolinium enhancement LGE In these patients fibrosis was found in the basal inferolateral myocardium and at the level of papillary muscles PMs This fibrosis is developed beyond the volume overload related to the MVP It is probably linked to the mechanical stretch acting upon the valve and the neighboring left ventricle LV myocardium RMRF is associated with a high degree of MR with specific features of mitral valve apparatus bi-leaflet prolapse with marked leaflet redundancy mitral annulus abnormalities ie Mitral-Annular Disjunction and more dilated LV It is also independently associated with the occurrence of cardiovascular events
Mitral valve repair MVr is the gold standard treatment for primary Mitral Regurgitation Very little data concerning the impact of preoperative RMRF on mitral valve surgery outcomes is available and the impact of myocardial fibrosis on the postoperative left ventricle remodeling has not been studied so far
No previous study compares preoperative and postoperative fibrosis evolution Thus no data exists regarding the postoperative evolution of this fibrosis and its relationship with ventricular arrhythmic risk after valve surgery Small observational studies have suggested that mitral valve surgery did not reduce the risk of ventricular arrhythmias in patients with bileaflet MVP
Finally the mechanisms involved in the development of regional myocardial replacement fibrosis within the left ventricle myocardium during the natural history of MVP cannot be understood with current standard medical imaging tools Numerical simulation technologies provide an innovative and in-vivo approach to assess the physical and pathological mechanisms causing this fibrosis They can also be used to assess the changes in mitral valve and myocardium dynamics after surgical mitral valve repair procedures
A large consortium involving physicians and scientists has been created to address these questions to fulfil our objectives over a 4 year period SIMR project
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ID-RCB | OTHER | 2021-A02902-39 | None |