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

NCT02879825 | Completed

• 1 other identifier: 2016-A00954-47
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Prolapse

Keywords

Ventricular Premature Complexes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Estimation of mitral regurgitation severity on echocardiography

  At inclusion

• Description and evaluation of ventricular myocardial deformation patterns

  Within 15 days

• Comparative evaluation of mitral regurgitation using echocardiography and cardiac MRI

  Within 15 days

Study Arms (4)

Group A

EXPERIMENTAL

Mitral valve prolapse without mitral regurgitation

Device: Cardiac MRI

Group B

EXPERIMENTAL

Mitral valve prolapse with trivial mitral regurgitation

Device: Cardiac MRI

Group C

EXPERIMENTAL

Mitral valve prolapse with moderate or mild mitral regurgitation and asymptomatic

Device: Cardiac MRI

Group D

EXPERIMENTAL

Mitral valve prolapse with severe mitral regurgitation or symptomatic

Device: Cardiac MRI

Interventions

Cardiac MRI DEVICE

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)

Also known as: 24-hour external loop recording, Exercise ECG

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mitral valve prolapse diagnosed in echocardiography
• Signed written consent
• Affiliation to social security
• No contraindication to MRI or exercise ECG
• Age above 18

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Nancy University Hospital, Department of Cardiology

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (3)

• 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.

  PMID: 26160859 BACKGROUND

• Huttin O, Pierre S, Venner C, Voilliot D, Sellal JM, Aliot E, Sadoul N, Juilliere 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.

  PMID: 27099279 BACKGROUND

• Huttin O, Girerd N, Jobbe-Duval A, Constant Dit Beaufils AL, Senage T, Filippetti L, Cueff C, Duarte K, Fraix A, Piriou N, Mandry D, Pace N, Le Scouarnec S, Capoulade R, Echivard M, Sellal JM, Marrec M, Beaumont M, Hossu G, Trochu JN, Sadoul N, Marie PY, Guenancia C, Schott JJ, Roussel JC, Serfaty JM, Selton-Suty C, Le Tourneau T. Machine Learning-Based Phenogrouping in MVP Identifies Profiles Associated With Myocardial Fibrosis and Cardiovascular Events. JACC Cardiovasc Imaging. 2023 Oct;16(10):1271-1284. doi: 10.1016/j.jcmg.2023.03.009. Epub 2023 May 17.

  PMID: 37204382 DERIVED

MeSH Terms

Conditions

Mitral Valve Prolapse; Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Heart Valve Prolapse; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Cardiac Complexes, Premature; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier HUTTIN, MD, MSc

  Department of Cardiology, Nancy University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: December 20, 2016
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-01

Locations

FR (1)