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Trial record 1 of 5 for:    Arrhythmia | "Mitral Valve Prolapse"
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Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse (STAMP: STretch and Myocardial Characterization in Arrhythmogenic Mitral Valve Prolapse) (STAMP)

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ClinicalTrials.gov Identifier: NCT02879825
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Olivier HUTTIN, Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment Phase
Mitral Valve Prolapse Device: Cardiac MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse
Actual Study Start Date : December 20, 2016
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Mitral valve prolapse without mitral regurgitation
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)

Other Names:
  • 24-hour external loop recording
  • Exercise ECG

Experimental: Group B
Mitral valve prolapse with trivial mitral regurgitation
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)

Other Names:
  • 24-hour external loop recording
  • Exercise ECG

Experimental: Group C
Mitral valve prolapse with moderate or mild mitral regurgitation and asymptomatic
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)

Other Names:
  • 24-hour external loop recording
  • Exercise ECG

Experimental: Group D
Mitral valve prolapse with severe mitral regurgitation or symptomatic
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)

Other Names:
  • 24-hour external loop recording
  • Exercise ECG




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879825


Contacts
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Contact: Olivier HUTTIN, MD, MSc +33383157355 o.huttin@chru-nancy.fr

Locations
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France
Nancy University Hospital, Department of Cardiology Recruiting
Vandoeuvre les Nancy, France, 54511
Contact: Olivier HUTTIN, MD, MSc    +33383157355    o.huttin@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Olivier HUTTIN, MD, MSc Department of Cardiology, Nancy University Hospital
Additional Information:

Publications:
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Responsible Party: Dr Olivier HUTTIN, Medical Doctor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02879825    
Other Study ID Numbers: 2016-A00954-47
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Keywords provided by Dr Olivier HUTTIN, Central Hospital, Nancy, France:
Ventricular Premature Complexes
Additional relevant MeSH terms:
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Mitral Valve Prolapse
Prolapse
Pathological Conditions, Anatomical
Heart Valve Prolapse
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases