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Lo studio clinico NCT06648577 (3DUsMR) per Chronic Primary Mitral Regurgitation è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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3D Ultrasound Myocardial Mechanical Wave Measurements (3DUsMR)

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06648577 (3DUsMR) è uno studio osservazionale per Chronic Primary Mitral Regurgitation, attualmente in arruolamento. Avviato il 9 ottobre 2024, prevede di arruolare 40 partecipanti. Sotto la guida di Ospedali universitari della Grande Parigi, dovrebbe concludersi entro il 14 novembre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 18 novembre 2025.
Sommario breve
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)

Descrizione dettagliata

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
Titolo ufficiale

3D Ultrasound Myocardial Mechanical Wave Measurements in Primary Mitral Regurgitation

Condizioni
Chronic Primary Mitral Regurgitation
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
  • 3DUsMR
  • APHP 240537
  • IDRCB (Altro identificativo) (2024-A01637-40)
Numero NCT
NCT06648577
Data di inizio (effettiva)
2024-10-09
Ultimo aggiornamento pubblicato
2025-11-18
Data di completamento (stimata)
2027-11-14
Arruolamento (previsto)
40
Tipo di studio
Osservazionale
Stato
In arruolamento
Parole chiave
Primary mitral regurgitation
High frame rate ultrasound imaging
CMR
Myocardial fibrosis
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
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.
Imaging ad ultrasuoni
The participants are scanned with an ultrasound scanner
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
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: * Severe primary MR patients (effective regurgitation orifice area ≥ 40mm²) with class I indication for surgery (symptoms and/or altered LV function as defined by left ventricular ejection fraction ≤60% and/or left ventricular end systolic diameter ≥40mm) (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)
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
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  • 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)

  • 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
Assistance Publique - Hôpitaux de Paris logoOspedali universitari della Grande Parigi961 studi clinici attivi da esplorare
Contatti principali dello studio
Contatto: Nadjib Hammoudi, MD, PhD, +33142163013, [email protected]
Contatto: Sebastien Salles, PhD, [email protected]
2 Centri dello studio in 1 paesi

Paris

Pitié Salpêtrière hospital, Paris, Paris, 75013, France
In arruolamento
Pitié- Salpêtrière hospital (AP-HP), Paris, Paris, 75013, France
Nadjb Hammoudi, MD, PhD, Contatto, +33142163013, [email protected]
Non ancora in arruolamento