Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse (STAMP: STretch and Myocardial Characterization in Arrhythmogenic Mitral Valve Prolapse)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A Mitral valve prolapse without mitral regurgitation |
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)
Other Names:
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| Experimental: Group B Mitral valve prolapse with trivial mitral regurgitation |
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)
Other Names:
|
| Experimental: Group C Mitral valve prolapse with moderate or mild mitral regurgitation and asymptomatic |
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)
Other Names:
|
| Experimental: Group D Mitral valve prolapse with severe mitral regurgitation or symptomatic |
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)
Other Names:
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Outcome Measures
Primary Outcome Measures
- Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia) [Within 15 days]
Occurrence of any ventricular arrythmia on external loop recording or exercise ECG
- Evidence of myocardial fibrosis on cardiac MRI [Within 15 days]
Visualisation of any late gadolinium enhancement
Secondary Outcome Measures
- Estimation of mitral regurgitation severity on echocardiography [At inclusion]
- Description and evaluation of ventricular myocardial deformation patterns [Within 15 days]
Comparison of deformation patterns using speckle-tracking echocardiography and strain in cardiac MRI
- Comparative evaluation of mitral regurgitation using echocardiography and cardiac MRI [Within 15 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Mitral valve prolapse diagnosed in echocardiography
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Signed written consent
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Affiliation to social security
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No contraindication to MRI or exercise ECG
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Age above 18
Exclusion Criteria:
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Mitral valve prolapse with severe regurgitation and instable hemodynamic state requiring urgent surgery
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Prior MRI with contrast within the last month
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Prior diagnosis of primary cardiomyopathy potentially responsible for myocardial fibrosis
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Contraindication to exercise ECG: severe handicap, poor physical capacity
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Contraindication to MRI: implantable device, claustrophobia, metal debris
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Renal insufficiency with creatinine clearance <30 ml/min or prior serious side effect related to infusion of a magnetic contrast agent
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Pregnant or breast-feeding women
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Minors <18 years old
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Mental illness or incapacity with incapacity to obtain informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nancy University Hospital, Department of Cardiology | Vandoeuvre les Nancy | France | 54511 |
Sponsors and Collaborators
- Central Hospital, Nancy, France
Investigators
- Principal Investigator: Olivier HUTTIN, MD, MSc, Department of Cardiology, Nancy University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Basso C, Perazzolo Marra M, Rizzo S, De Lazzari M, Giorgi B, Cipriani A, Frigo AC, Rigato I, Migliore F, Pilichou K, Bertaglia E, Cacciavillani L, Bauce B, Corrado D, Thiene G, Iliceto S. Arrhythmic Mitral Valve Prolapse and Sudden Cardiac Death. Circulation. 2015 Aug 18;132(7):556-66. doi: 10.1161/CIRCULATIONAHA.115.016291. Epub 2015 Jul 9.
- Huttin O, Pierre S, Venner C, Voilliot D, Sellal JM, Aliot E, Sadoul N, Juillière Y, Selton-Suty C. Interactions between mitral valve and left ventricle analysed by 2D speckle tracking in patients with mitral valve prolapse: one more piece to the puzzle. Eur Heart J Cardiovasc Imaging. 2017 Mar 1;18(3):323-331. doi: 10.1093/ehjci/jew075.
- 2016-A00954-47