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

NCT ID: NCT02879825

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-20
• Study Completion Date: 2021-05-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group B

Mitral valve prolapse with trivial mitral regurgitation

Group Type: EXPERIMENTAL

Cardiac MRI

Intervention Type: 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)

Group C

Mitral valve prolapse with moderate or mild mitral regurgitation and asymptomatic

Group Type: EXPERIMENTAL

Cardiac MRI

Intervention Type: 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)

Group D

Mitral valve prolapse with severe mitral regurgitation or symptomatic

Group Type: EXPERIMENTAL

Cardiac MRI

Intervention Type: 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)

Group A

Mitral valve prolapse without mitral regurgitation

Group Type: EXPERIMENTAL

Cardiac MRI

Intervention Type: 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)

Interventions

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)

Intervention Type: DEVICE

Other Intervention Names

24-hour external loop recording; Exercise ECG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Dr Olivier HUTTIN

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olivier HUTTIN, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Nancy University Hospital

Locations

Nancy University Hospital, Department of Cardiology

Vandœuvre-lès-Nancy, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 26160859 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27099279 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37204382 (View on PubMed)

Other Identifiers

2016-A00954-47

Identifier Type: -

Identifier Source: org_study_id