Ignite Creation Date:
2024-05-06 @ 4:03 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04852731
Status:
RECRUITING
Last Update Posted:
2022-08-09
First Post:
2021-04-16
Brief Title:
STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Dynamic Evaluation of Myocardial Fibrosis and Structural Determinants of Ventricular Arrhythmia in Mitral Valve Prolapse STAMP-2 STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2
Status:
RECRUITING
Status Verified Date:
2022-08
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:
STAMP-2
Brief Summary:
Mitral valve prolapse MVP is a frequent affection of the mitral valve with a prevalence of 2-3 in the general population This valvular disease is generally considered as benign but may at term evolve toward mitral valve regurgitation of various severity andor arrhythmia
Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography Subsequent examinations 24-hour external loop recording exercise electrocardiogram cardiac Magnetic Resonance Imaging and a close follow-up can be proposed to the patient depending on its condition
More recently detection of myocardial fibrosis and a mitral ring disjunction among patients with MVP were associated with the occurrence of severe ventricular arrhythmia
The investigators hypothesize that ventricular remodeling over time is mediated by the progression of mitral insufficiency severity from myocardial fibrosis secondary to MVP and possibly promoted by other mitral valve abnormalities This remodeling characterized by circulating biomarkers and imaging MRI and echocardiography could allow the identification of patients with a higher risk of severe ventricular arrhythmia
The main objective of this study is to identify prognostic factors for unfavorable evolution ventricular remodeling or a rhythm disorder event at 3 years from initial assessments in MVP patients
Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography Subsequent examinations 24-hour external loop recording exercise electrocardiogram cardiac Magnetic Resonance Imaging and a close follow-up can be proposed to the patient depending on its condition
More recently detection of myocardial fibrosis and a mitral ring disjunction among patients with MVP were associated with the occurrence of severe ventricular arrhythmia
The investigators hypothesize that ventricular remodeling over time is mediated by the progression of mitral insufficiency severity from myocardial fibrosis secondary to MVP and possibly promoted by other mitral valve abnormalities This remodeling characterized by circulating biomarkers and imaging MRI and echocardiography could allow the identification of patients with a higher risk of severe ventricular arrhythmia
The main objective of this study is to identify prognostic factors for unfavorable evolution ventricular remodeling or a rhythm disorder event at 3 years from initial assessments in MVP patients
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