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

January 20, 2022 updated by: Dr Olivier HUTTIN, Central Hospital, Nancy, France

Myocardial Characterization of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre les Nancy, France, 54511
        • Nancy University Hospital, Department of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 15 days
Evidence of myocardial fibrosis on cardiac MRI
Time Frame: Within 15 days
Visualisation of any late gadolinium enhancement
Within 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimation of mitral regurgitation severity on echocardiography
Time Frame: At inclusion
At inclusion
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
Within 15 days
Comparative evaluation of mitral regurgitation using echocardiography and cardiac MRI
Time Frame: Within 15 days
Within 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Olivier HUTTIN, MD, MSc, Department of Cardiology, Nancy University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2016

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A00954-47

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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