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

Mitral Valve Prolapse Clinical Trial

— STAMP  

Official title:

Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879825
• Other study ID #: 2016-A00954-47
• Status: Completed
• Phase: N/A
• Start date: December 20, 2016
• Est. completion date: May 31, 2021

Study information

• Verified date: January 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Prolapse
• Prolapse

Intervention

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)

Locations

Country	Name	City	State
France	Nancy University Hospital, Department of Cardiology	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia)	Occurrence of any ventricular arrythmia on external loop recording or exercise ECG	Within 15 days
Primary	Evidence of myocardial fibrosis on cardiac MRI	Visualisation of any late gadolinium enhancement	Within 15 days
Secondary	Estimation of mitral regurgitation severity on echocardiography		At inclusion
Secondary	Description and evaluation of ventricular myocardial deformation patterns	Comparison of deformation patterns using speckle-tracking echocardiography and strain in cardiac MRI	Within 15 days
Secondary	Comparative evaluation of mitral regurgitation using echocardiography and cardiac MRI		Within 15 days