Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse (STAMP: STretch and Myocardial Characterization in Arrhythmogenic Mitral Valve Prolapse) (STAMP)
Primary Purpose
Mitral Valve Prolapse
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Mitral Valve Prolapse focused on measuring Ventricular Premature Complexes
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
Sites / Locations
- Nancy University Hospital, Department of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Group D
Arm Description
Mitral valve prolapse without mitral regurgitation
Mitral valve prolapse with trivial mitral regurgitation
Mitral valve prolapse with moderate or mild mitral regurgitation and asymptomatic
Mitral valve prolapse with severe mitral regurgitation or symptomatic
Outcomes
Primary Outcome Measures
Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia)
Occurrence of any ventricular arrythmia on external loop recording or exercise ECG
Evidence of myocardial fibrosis on cardiac MRI
Visualisation of any late gadolinium enhancement
Secondary Outcome Measures
Estimation of mitral regurgitation severity on echocardiography
Description and evaluation of ventricular myocardial deformation patterns
Comparison of deformation patterns using speckle-tracking echocardiography and strain in cardiac MRI
Comparative evaluation of mitral regurgitation using echocardiography and cardiac MRI
Full Information
NCT ID
NCT02879825
First Posted
August 23, 2016
Last Updated
January 20, 2022
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT02879825
Brief Title
Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse (STAMP: STretch and Myocardial Characterization in Arrhythmogenic Mitral Valve Prolapse)
Acronym
STAMP
Official Title
Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2016 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Prolapse
Keywords
Ventricular Premature Complexes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Mitral valve prolapse without mitral regurgitation
Arm Title
Group B
Arm Type
Experimental
Arm Description
Mitral valve prolapse with trivial mitral regurgitation
Arm Title
Group C
Arm Type
Experimental
Arm Description
Mitral valve prolapse with moderate or mild mitral regurgitation and asymptomatic
Arm Title
Group D
Arm Type
Experimental
Arm Description
Mitral valve prolapse with severe mitral regurgitation or symptomatic
Intervention Type
Device
Intervention Name(s)
Cardiac MRI
Other Intervention Name(s)
24-hour external loop recording, Exercise ECG
Intervention Description
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)
Primary Outcome Measure Information:
Title
Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia)
Description
Occurrence of any ventricular arrythmia on external loop recording or exercise ECG
Time Frame
Within 15 days
Title
Evidence of myocardial fibrosis on cardiac MRI
Description
Visualisation of any late gadolinium enhancement
Time Frame
Within 15 days
Secondary Outcome Measure Information:
Title
Estimation of mitral regurgitation severity on echocardiography
Time Frame
At inclusion
Title
Description and evaluation of ventricular myocardial deformation patterns
Description
Comparison of deformation patterns using speckle-tracking echocardiography and strain in cardiac MRI
Time Frame
Within 15 days
Title
Comparative evaluation of mitral regurgitation using echocardiography and cardiac MRI
Time Frame
Within 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier HUTTIN, MD, MSc
Organizational Affiliation
Department of Cardiology, Nancy University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nancy University Hospital, Department of Cardiology
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
26160859
Citation
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.
Results Reference
background
PubMed Identifier
27099279
Citation
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.
Results Reference
background
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Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse (STAMP: STretch and Myocardial Characterization in Arrhythmogenic Mitral Valve Prolapse)
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