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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Other Identifier | 2024-A01637-40 |
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Primary mitral regurgitation (MR) is a frequent disease that can ultimately lead to heart failure. Primary MR represents the second most prevalent cause of cardiac valve surgery in high income countries. Progressive myocardial fibrosis due to chronic volume overload is recognized as a pathophysiological substrate of altered LV function in primary MR. As fibrosis leads to increased myocardial stiffness, ultrasound mechanical wave propagation measurements within the myocardium could provide important clinical information. Natural mechanical wave velocity (MWV) imaging, using High-frame-rate (HFR) echocardiography has emerged as a promising tool to evaluate myocardial stiffness.
The objective is study is to evaluate the correlation between the LV myocardial stiffness (as assessed by 3D ultrasound myocardial MWV mapping) and myocardial interstitial fibrosis as measured using CMR (myocardial extracellular volume measure)
After being informed about the study. All patients giving written informed consent will undergo in a routine practice:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive 2D/3D echocardiography | This an observational non interventional study. All patients will have both comprehensive 2D/3D echocardiography (including MWV imaging) and cardiac CMR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound imaging | Procedure | The participants are scanned with an ultrasound scanner |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and myocardial fibrosis assessed with CMR (ECV measure). | The speed of the mechanical wave in left ventricle will be measured (in m/s) using 3D high frame rate ultrasound imaging. Left ventricular interstitial fibrosis will be assessed by the measure of myocardial extracellular volume fraction (ECV, in %) by CMR. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and myocardial fibrosis assessed with CMR (T1 mapping) | The speed of the mechanical wave in left ventricle will be measured (in m/s) using 3D high frame rate ultrasound imaging. Left ventricular fibrosis will be assessed from CMR by pre and post contrast T1 mapping (in milliseconds) | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and exercice capacity | The speed of the mechanical wave in left ventricle will be measured (in m/s) using 3D high frame rate ultrasound imaging. The exercise capacity will be measured thought symptom-limited combined exercise echocardiography and oxygen uptake measurements (in watts and using peak oxygen uptake expressed as mL/kg) |
Inclusion Criteria:
Exclusion Criteria:
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The study will include adult patients with chronic primary mitral regurgitation who have been referred to our tertiary cardiology center as part of their routine care. These are the typical patients with chronic primary mitral regurgitation whom we aim to better phenotype using the new 3D ultrasound mapping technology for MWV (mechanical wave velocity).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadjib Hammoudi, MD, PhD | Contact | +33142163013 | nadjib.hammoudi@aphp.fr | |
| Sebastien Salles, PhD | Contact | sebastien.salles@cnrs.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pitié Salpêtrière hospital | Recruiting | Paris | Paris | 75013 | France | |
| Pitié- Salpêtrière hospital (AP-HP) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32861651 | Result | Salles S, Espeland T, Molares A, Aase SA, Hammer TA, Stoylen A, Aakhus S, Lovstakken L, Torp H. 3D Myocardial Mechanical Wave Measurements: Toward In Vivo 3D Myocardial Elasticity Mapping. JACC Cardiovasc Imaging. 2021 Aug;14(8):1495-1505. doi: 10.1016/j.jcmg.2020.05.037. Epub 2020 Aug 26. |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| To assess the link between left ventricular stiffness as assessed by 3D Mechanical wave velocity and the 3 different clinical stages of chronic mitral regurgitation | The speed of the mechanical wave in left ventricle will be measured (in m/s) using 3D high frame rate ultrasound imaging. The clinical stages of the patients are defined as follow:
| baseline |
| To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity, left ventricular mass and global longitudinal strain | The speed of the mechanical wave in left ventricle will be measured (in m/s) using 3D high frame rate ultrasound imaging. Left ventricular mass will be measured (in grammes /m²) using echocardiography and CMR Global longitudinal strain (in %) will be measured from echocardiography and CMR from apical 4, 2 and 3 chambers views. | baseline |
| 1 year |
| To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and mitral regurgitation severity | The speed of the mechanical wave in left ventricle will be measured (in m/s) using 3D high frame rate ultrasound imaging. Mitral regurgitation severity will be assessed by echocardiography (effective regurgitation orifice area in mm² and regurgitation volume in mL) and using CMR (regurgitation orifice area, volume and regurgitation fraction). | 1 year |
| Not yet recruiting |
| Paris |
| Paris |
| 75013 |
| France |
|
| D055585 |
| Physical Phenomena |