3D Ultrasound Myocardial Mechanical Wave Measurements

Официальное название

3D Ultrasound Myocardial Mechanical Wave Measurements in Primary Mitral Regurgitation

Обзор

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)

Подробное описание

After being informed about the study. All patients giving written informed consent will undergo in a routine practice:

1. echocardiography (2D/3D), 2. CMR imaging, 3. electrocardiogram 24 hours monitoring, 4. blood sampling including brain natriuretic peptide measurement, 5. symptom-limited combined exercise echocardiography and oxygen uptake measurements

Вмешательства

• Процедура Ultrasound imaging
  The participants are scanned with an ultrasound scanner

Первичные конечные точки

• To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and myocardial fibrosis assessed with CMR (ECV measure). [Срок оценки: baseline]

Вторичные конечные точки (3)

• To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and myocardial fibrosis assessed with CMR (T1 mapping) [Срок оценки: baseline]
• 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 [Срок оценки: baseline]
• To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity, left ventricular mass and global longitudinal strain [Срок оценки: baseline]

Критерии участия

Критерии включения

• Severe primary MR patients (effective regurgitation orifice area ≥ 40mm²) with class I indication for surgery (symptoms and/or altered conventional parameters of LV function) (n=10 patients)
• Severe primary MR patients (effective regurgitation orifice area ≥ 40mm²) without class I indication of surgery (n=20 patients)
• Mild to moderate primary MR patients as defined by effective regurgitation orifice area ≥ 20mm² and < 40mm² (n=10 patients)

Критерии исключения

• Permanent atrial fibrillation
• Acute primary severe MR
• Secondary MR
• Previous cardiac surgery of any kind
• Other severe left sided valvular disease
• Coronary artery disease
• Congenital cardiac disorder

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 2 центра

• Pitié Salpêtrière hospital — Paris
• Pitié- Salpêtrière hospital (AP-HP) — Paris

Публикации

• 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. PMID 32861651

Идентификаторы

NCT: NCT06648577 · APHP 240537 · IDRCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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