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Completed

NCT Number: NCT02879825

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nancy University Hospital, Department of Cardiology

Vandœuvre-lès-Nancy, 54511, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: 24-hour external loop recording, Exercise ECG

Primary outcomes

  1. Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia)

    Time frame: Within 15 days

    Occurrence of any ventricular arrythmia on external loop recording or exercise ECG

  2. Evidence of myocardial fibrosis on cardiac MRI

    Time frame: Within 15 days

    Visualisation of any late gadolinium enhancement

Secondary outcomes

  1. Estimation of mitral regurgitation severity on echocardiography

    Time frame: At inclusion

  2. Description and evaluation of ventricular myocardial deformation patterns

    Time frame: Within 15 days

    Comparison of deformation patterns using speckle-tracking echocardiography and strain in cardiac MRI

  3. Comparative evaluation of mitral regurgitation using echocardiography and cardiac MRI

    Time frame: Within 15 days

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse

Acronym: STAMP

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2016
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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