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

Study Overview
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Brief Summary
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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.

Official Title
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Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse

Conditions
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Mitral Valve Prolapse

Intervention / Treatment
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* Device: Cardiac MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mitral valve prolapse diagnosed in echocardiography Signed written consent Affiliation to social security No contraindication to MRI or exercise ECG Age above 18 Exclusion Criteria: Mitral valve prolapse with severe regurgitation and instable hemodynamic state requiring urgent surgery Prior MRI with contrast within the last month Prior diagnosis of primary cardiomyopathy potentially responsible for myocardial fibrosis Contraindication to exercise ECG: severe handicap, poor physical capacity Contraindication to MRI: implantable device, claustrophobia, metal debris Renal insufficiency with creatinine clearance <30 ml/min or prior serious side effect related to infusion of a magnetic contrast agent Pregnant or breast-feeding women Minors <18 years old Mental illness or incapacity with incapacity to obtain informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Mitral valve prolapse without mitral regurgitation | Device: Cardiac MRI<br>* 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)<br>* Other names: Exercise ECG;|
| Experimental: Group B<br>Mitral valve prolapse with trivial mitral regurgitation | Device: Cardiac MRI<br>* 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)<br>* Other names: Exercise ECG;|
| Experimental: Group C<br>Mitral valve prolapse with moderate or mild mitral regurgitation and asymptomatic | Device: Cardiac MRI<br>* 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)<br>* Other names: Exercise ECG;|
| Experimental: Group D<br>Mitral valve prolapse with severe mitral regurgitation or symptomatic | Device: Cardiac MRI<br>* 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)<br>* Other names: Exercise ECG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia) | Occurrence of any ventricular arrythmia on external loop recording or exercise ECG | Within 15 days | 
| Evidence of myocardial fibrosis on cardiac MRI | Visualisation of any late gadolinium enhancement | Within 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of mitral regurgitation severity on echocardiography |  | At inclusion | 
| Description and evaluation of ventricular myocardial deformation patterns | Comparison of deformation patterns using speckle-tracking echocardiography and strain in cardiac MRI | Within 15 days | 
| Comparative evaluation of mitral regurgitation using echocardiography and cardiac MRI |  | Within 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricular Premature Complexes