NCT02879825

Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse (STAMP: STretch and Myocardial Characterization in Arrhythmogenic Mitral Valve Prolapse)

Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Mitral valve prolapse (MVP) is a frequent affection of the mitral valve or its sub-valvular apparatus 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 and/or arrhythmia. Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography and only patients with significant mitral regurgitation will undergo subsequent examination (24-hour external loop recording, exercise ECG, cardiac MRI) and a close follow-up. External loop recording and exercise ECG have an interest in the identification of patients presenting with arrhythmic complications, such as premature ventricular contractions, and in the global evaluation of hemodynamic consequences of the mitral regurgitation. More recently, detection of myocardial fibrosis among patients with MVP and severe ventricular arrhythmia has been identified. Fibrosis could evolve independently of the valvular regurgitation's severity and could be a substrate (myocardial scar) leading to ventricular arrhythmia. However, no study has specifically characterized myocardial lesions among patients with MVP and none, or not significant, mitral regurgitation. Using cardiac magnetic resonance imaging (MRI), gold standard technique in myocardial imaging and characterization, and echocardiography, particularly speckle-tracking imaging, identification of static (fibrosis) and/or dynamic (ventricular systolic deformation patterns using speckle-tracking strain) myocardial lesions. Identification of patients with impaired deformation patterns, fibrosis or with premature ventricular contractions may isolate a sub-group of patients with a higher risk of severe ventricular arrhythmia for whom a closer follow-up could be justified.

Conditions

• Mitral Valve Prolapse

Interventions

Type	Name	Description
DEVICE	Cardiac MRI	Group-A patients, with mitral valve prolapse but no mitral regurgitation, will undergo specifically for research purposes a cardiac MRI, 24-hour external loop recording and exercise ECG on top of regular echocardiography evaluation. Realization of these examinations will be performed according to recommendations for patients with mitral regurgitation (groups B, C and D)

Timeline

• Start date: 2016-12-20
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2016-08-26
• Last updated: 2022-02-03

Locations

1 site across 1 country: France