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Recruiting NCT06648577

3D Ultrasound Myocardial Mechanical Wave Measurements

— Observational Chronic Primary Mitral Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound imaging.
Who it may be relevant to
Registry conditions: Chronic Primary Mitral Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

3D Ultrasound Myocardial Mechanical Wave Measurements in Primary Mitral Regurgitation

Overview

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)

Detailed description

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

Interventions

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

Primary outcome measures

  • To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and myocardial fibrosis assessed with CMR (ECV measure). [Time frame: baseline]
Secondary outcome measures (3)
  • To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity and myocardial fibrosis assessed with CMR (T1 mapping) [Time frame: 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 [Time frame: baseline]
  • To assess the correlation between left ventricular stiffness as assessed by 3D Mechanical wave velocity, left ventricular mass and global longitudinal strain [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • Pitié Salpêtrière hospital — Paris
  • Pitié- Salpêtrière hospital (AP-HP) — Paris

Publications

  • 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

Identifiers

NCT: NCT06648577 · APHP 240537 · IDRCB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗