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

Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02879825
Acronym
STAMP
Enrollment
239
Registered
2016-08-26
Start date
2016-12-20
Completion date
2021-05-31
Last updated
2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Prolapse

Keywords

Ventricular Premature Complexes

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.

Interventions

DEVICECardiac 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)

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia)Within 15 daysOccurrence of any ventricular arrythmia on external loop recording or exercise ECG
Evidence of myocardial fibrosis on cardiac MRIWithin 15 daysVisualisation of any late gadolinium enhancement

Secondary

MeasureTime frameDescription
Estimation of mitral regurgitation severity on echocardiographyAt inclusion
Description and evaluation of ventricular myocardial deformation patternsWithin 15 daysComparison of deformation patterns using speckle-tracking echocardiography and strain in cardiac MRI
Comparative evaluation of mitral regurgitation using echocardiography and cardiac MRIWithin 15 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026